FDA 对新加坡 TSP Solutions 发出警告信，指其防晒药品成品检验与组分鉴别存在 CGMP 缺陷

Delivery Method:

VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED

Reference #:

320-27-07

Product:

Drugs
Over-the-Counter Drugs

Recipient:

Recipient Name

Mr. Min-tsek Lau

Recipient Title

Managing Director

TSP Solutions Pte. Ltd.

Block 998 Toa Payoh North
#05-05/06 Mapletree Industrial
318993
Singapore

[email protected]

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

October 22, 2026

WARNING LETTER
Reference number: 320-27-07

To Mr. Min-tsek Lau:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of records submitted from your facility. 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 action without further notice.

FDA Review

Violations were identified and documented during review of your drug manufacturing facility, TSP Solutions Pte. Ltd., FDA Establishment Identifier (FEI) 3023093622. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our September 9, 2025, request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.

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

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request 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)).

Violations of the Federal Food, Drug, and Cosmetic Act

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

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release; and, your firm failed to conduct appropriate laboratory testing, as necessary, for each batch of drug product required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).

Your firm manufactures sunscreen drug products.

Based on the records and information you provided, you did not demonstrate that you conduct adequate finished drug product testing on your drug products. Specifically, neither the certificate of analysis (COA) reports nor the batch records that you provided include an appropriate assay test for active ingredient content or impurity testing. In addition, your records do not include appropriate microbiological testing.

Full release testing, including strength and identity testing of the active ingredient, as well as appropriate microbiological testing, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to ensure that your drug products conform to appropriate specifications before release.

In response to this letter, provide:

• 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 to 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.

2. 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)).

Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your drug products. Your response also indicated that you accept your supplier’s COA without verifying the test results at appropriate intervals. Verification of component quality is performed only by reviewing the COAs and material safety data sheets provided by the suppliers.

Without adequate testing and without establishing the reliability of your component suppliers’ test analyses at appropriate intervals, you do not have scientific evidence that your raw materials conform to appropriate specifications before you use them in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before you use them in production to ensure 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 if they are reliable and appropriately qualified
  o an assessment of all materials to determine whether they are consistently of acceptable quality based on thorough historical review
  o a review to ensure assigned expiration or retest dates are appropriate (supported by data)
  o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions
  o vigilant lifecycle monitoring of all suppliers using sound quality risk management practices
  o based on this thorough review, summarize a systemic CAPA that remediates the materials system to ensure ongoing lifecycle oversight of vendor performance and prevents use of unsuitable components (ingredients), containers and closures.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of component 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.

3. 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).

Based on the records and information you provided, your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:

• Adequate procedures ensuring appropriate production and process controls for drug product manufacturing and qualification of equipment used to manufacture drug products (21 CFR 211.100(a)).
• Adequate laboratory control procedures to ensure drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).
• The establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).

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.

CGMP Consultant Recommended

Based upon the nature of the violations we identified in your response, 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

As previously stated, 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.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on August 14, 2026.

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 inspect to verify that you have completed corrective actions to any violations.

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at TSP Solutions Pte. Ltd., at Block 998 Toa Payoh North, #05-05/06 Mapletree Industrial, Singapore 318993, Singapore, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

Send your written response to [email protected] within 15 business days of receipt of this letter. Identify your written response with FEI 3023093622 and ATTN: Bryce Hammer in the subject line of the email.

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

Cc: Registered U.S. Agent
Mr. David Lennarz
Registrar Corp
[email protected]