FDA 就 OOS 调查与实验室控制缺陷向 SnugZ USA 发出警告信（编号 320-26-131）

Delivery Method:

Via Electronic Mail - Return Receipt Requested

Reference #:

320-26-131

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Mr. Brandon K. Mackay

Recipient Title

President and Chief Executive Officer

SnugZ USA, Inc.

9258 South Prosperity Road
West Jordan, UT 84081-6161
United States

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

September 28, 2026

WARNING LETTER
Reference number: 320-26-131

To Mr. Brandon K. Mackay:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your products and facilities. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

FDA Inspection

Violations were observed and documented during an inspection of your drug manufacturing facility, SnugZ USA, Inc., FDA Establishment Identifier (FEI) 3009188709, at 9258 South Prosperity Road, West Jordan, from April 27 to May 1, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your May 22, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Your firm manufactures over-the-counter (OTC) drug products such as (b)(4) and (b)(4), primarily distributed by your customers as promotional items. Your firm routinely failed to investigate out-of-specification (OOS) chemical and microbiological results for drug products and for (b)(4) system monitoring samples. Your firm retested failing samples or prepared and tested new samples without justification until your analysts obtained passing results. Your firm used these results to release drug product to the market without appropriate investigations into the original failing results.

Additionally, your firm failed to conduct adequate complaint investigations. Your investigations consisted largely of email correspondence and lacked proper root cause determination and implementation of corrective actions and preventive actions (CAPA). Inadequate investigations are a repeat observation identified at your firm.

In your response, you commit to a retrospective review of the OOS results and implemented an interim “full stop” for any initial OOS result. You also state you will review prior OOS results and customer complaints to determine product impact and ensure release decisions were scientifically justified. Your response is inadequate. You failed to provide plans on how you will ensure that OOS results and complaints are always appropriately handled. You also failed to provide adequate details of your remediations to ensure they are sustainable to prevent repeat violations.

Passing retest results alone cannot serve as the basis for invalidating OOS results. As a manufacturer, you have a responsibility to fully investigate aberrant chemical and microbial test results that may impact drug product quality. For more information about handling out-of-specification and failing test results and documenting your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/158416/download.

In response to this letter, provide:

• A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
• A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS result:
  o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.
  o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.
  o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.
• An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.

• A comprehensive, independent review of your overall complaint system, including a retrospective review of all complaints for the last three years from the initial date of inspection with an assessment that includes, but is not limited to:
  o Nature of complaint, and potential associated risk
  o Date of first notification and subsequent contacts with complainant
  o Timing and sufficiency of follow-ups with the complainant to obtain photographs and the complaint sample, as well as to obtain any additional contextual information. Determination of whether relevant complaint samples were available and extent of efforts to obtain the complaint sample. If insufficient attempts were made, identify the root cause(s) for not adequately pursuing their return.
  o Review of long-term history for similar or same defects.
  o Identification of potential causes of the defect that led to the complaint, including evaluation of whether the scientific justification and evidence relating to the identified root cause(s) were adequately documented. In the event a complaint was attributed to factors outside of the firm’s control(e.g., user error), assess the strength of this determination and whether it was based on conclusive or inconclusive information.

  o CAPA steps taken including, but not limited to, manufacturing/quality improvements (e.g., manufacturing operation, raw materials, supplier, quality control), as well as recalls or heightened quality surveillance (additional testing/examinations, adding batch to stability program).
  o For all complaint investigations found by the retrospective review to be deficient due to insufficient root cause or CAPA, perform a thorough analysis of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, OOS result history, batch failure history).
  o Based upon this independent review, provide a comprehensive assessment of the complaint system that identifies all deficiencies and needed improvements.

2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

Your test method procedures allowed multiple retesting of samples following an OOS result, often until an acceptable result is obtained. For example, your (b)(4) standard operating procedure (SOP) described repreparing OOS samples and retesting multiple times without requiring investigations. The SOP requires notifying quality control management only after (b)(4) OOS results. Your procedure also stated that if an unidentified peak is observed during chromatographic analysis, it is at the discretion of the analyst to consult the Quality Control manager to determine whether further action is needed.

Additionally, your (b)(4) Microbial Testing SOP allows retesting following an initial failure. Also, your SOP says that if the retest fails, your analysts are to use the (b)(4), a second microbiological testing instrument. You routinely invalidated failing batch release results from the (b)(4) system and used the passing (b)(4) results to release product to the market without scientific justification. You could not provide any data to support this tiered testing approach or the validation of one method as superior to the other.

In your response, you commit to implementing an interim requirement to open an OOS investigation for all initial failing results. You also commit to revising your OOS procedure to define when repeat testing, re-injection, re-vialing, etc. are allowed, when Quality Assurance authorization is required, and to require scientific justification and documentation of all data generated. Your response is inadequate because it fails to recognize the scope of your poor analytical practices. You did not address revisions to specific analytical methods, training, or systemic remediation of your routine practice of invalidating OOS results and retesting. Inadequate laboratory controls have previously been observed at your firm, and your earlier commitments to correct them and prevent their recurrence were not effective.

These are unscientific practices and objectionable under CGMP.

Chemical and microbial release testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the Quality Unit’s (QU) ability to exercise its function of ensuring compliance with applicable standards.

In response to this letter, provide:

• A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
• A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a lot disposition decision.
• An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed in the United States that are within expiry as of the date of this letter.
• A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.
• A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:
  o Quality unit oversight of laboratory investigations
  o Identification of adverse laboratory control trends
  o Resolution of causes of laboratory variation
  o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified
  o Adequate scoping of each investigation and its CAPA
  o Revised OOS investigation procedures with these and other remediations
  o A similar review and remediation of your system for handling out-of-limit findings (i.e., data that falls outside action limits)

3. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

You failed to perform adequate identity testing of incoming components used in the manufacture of your OTC drug products. You also failed to collect representative samples from each lot of components. In some cases, you relied on identity test results from previously tested component lots when receiving new shipments of the same component lot. Additionally, you failed to establish the reliability of your suppliers’ certificates of analyses (COAs) at appropriate intervals and accepted COAs without confirmatory testing.

In your response, you commit to revising your supplier qualification and raw material sampling SOPs. You commit to reducing testing criteria and identifying an outside laboratory to perform confirmatory testing for your suppliers’ COAs. You also commit to testing each shipment of components received prior to use. Your response is inadequate. You did not provide sufficient details about your planned procedural improvements, the testing to be performed, your strategy for reduced testing, nor did you commit to evaluating component retains.

Without adequate testing and verification of supplier results, you do not have scientific evidence that your incoming components conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality.

In response to this letter, provide:

• A comprehensive, independent review of your material system including, but not limited to:
  o Evaluating all suppliers of materials (components, containers, and closures) to determine whether they are reliable and appropriately qualified
  o An assessment of all materials to determine whether they are consistently of acceptable quality
  o A review to ensure assigned expiration or retest dates are appropriate and supported by data
  o Adequacy of the supplier qualification program and its selection, qualification, and disqualification provisions.
• Based on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
• A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program.
• A summary of your program for qualifying and overseeing contract facilities that test the components and drug products you manufacture.

4. Your firm’s quality unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your QU failed to establish and exercise its authority to adequately oversee the manufacturing, testing, packing, holding, review, and release of your OTC drug products. Your firm’s inadequate quality oversight resulted in significant deficiencies in analytical and production record review, investigations, and quality system controls to ensure compliance with CGMP requirements. For example, your QU failed to ensure:

• Adequate procedures ensuring appropriate document controls of production and test records. (21 CFR 211.22(d)).
• Adequate validation of cleaning procedures (21 CFR 211.67(b)).
• Performance of periodic (i.e. at least annual) product quality reviews (21 CFR 211.180(e)).
• Adequate documentation of each significant step in batch production records (21 CFR 211.188(b)).
• Adequate review of all production and test records, including deviations, OOS results, and audit trails, prior to releasing drug product to the market (21 CFR 211.192).

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your QU is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.

Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download.

Repeat Violations at Facility

In a previous April 1, 2022 Regulatory Meeting, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your responses. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

CGMP Consultant

Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Conclusion

You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

Send your written response to [email protected] within 15 business days of receipt of this letter. Identify your written response with FEI 3009188709 and ATTN: Compliance Officer Christina Capacci-Daniel in the letter.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters to www.FDA.gov.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration