FDA公布OPS International 483观察记录，涉无菌组装环境监测及投料双人复核缺陷

2026年10月1日，FDA公布一则483缺陷报告。

检查对象：OPS International Inc

检查日期：2026 年 8 月 20 日 — 2026 年 9 月 3 日

检查员：Mindy M Chou、Michelle Lin

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

在对贵公司开展检查过程中我们发现：

OBSERVATION 1

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

无菌生产区域的环境条件监测体系存在缺陷。

Specifically,

具体如下：

(A) The firm's environmental monitoring procedure does not require viable environmental monitoring during the initial aseptic setup of the (b)(4) filling line within the (b)(4) or during the initial aseptic setup of the (b)(4) automated filling machine positioned under (b)(4), HEPA-filtered unidirectional airflow enclosure. Per SOP-009, Environmental Monitoring of the Controlled Production Areas, environmental monitoring is not required to commence until aseptic connections setup activities have occurred.

（A）公司环境监测规程未要求在(b)(4)灌装线于(b)(4)内开展初始无菌组装阶段，以及放置在(b)(4)高效过滤单向流罩下方的(b)(4)自动灌装机进行初始无菌组装阶段实施活菌环境监测。根据SOP-009《受控生产区域环境监测规程》，仅当无菌连接组装操作完成后才启动环境监测。

(1) On August 26, 2026, we observed operator (b)(4) performing set-up of the (b)(4) for the (b)(4) automated filling machine (Equipment ID #(b)(4)) for the filling of Calcium Chloride (Lot #H24A01-26). No environmental monitoring plates were present within the ISO 5 critical area under the (b)(4) unidirectional airflow unit during this setup activity.

（1）2026年8月26日，我们观察到操作员(b)(4)为灌装氯化钙（批号H24A01-26）的(b)(4)自动灌装机（设备编号(b)(4)）开展(b)(4)组装。该组装操作期间，(b)(4)单向流装置下方的ISO5级关键区域内未放置环境监测平板。

(2) According to the batch record for Myer's Cocktail (Lot # G27A05-26, Exp. 26 Nov 2026), equipment set-up of the (b)(4) auto filler, located inside the ISO (b)(4) in Suite (b)(4) began at 08:01. The first passive air sample was not opened until 08:21 on 30 July 2026.

（2）根据迈尔混合注射液（批号G27A05-26，有效期至2026年11月26日）批记录，位于(b)(4)洁净套间内ISO(b)(4)区域的(b)(4)自动灌装机设备组装于08:01开始。首份被动空气采样平板直至2026年7月30日08:21才开启。

(B) The firm's personnel monitoring program does not include microbiological monitoring of gown locations for Sterile Techs who perform set-up of the(b)(4) filling line or set-up of the(b)(4) automated filling machine. Gown monitoring at a defined schedule, supported by scientific justification, is not included in the program.

（B）公司人员监测方案未对执行(b)(4)灌装线、(b)(4)自动灌装机组装操作的无菌技术人员开展无菌服分区微生物监测。方案中未设置经科学论证、按既定周期开展的无菌服监测。

(1) On August 21, 2026, we observed Sterile Tech (b)(4) performing line setup for the filling of Biotin 0.5 mg/mL (Lot # H17A05-26) with his head, body, and sleeves inside the ISO 5 (b)(4) chamber without any concurrent personnel monitoring.

（1）2026年8月21日，我们观察到无菌技术人员(b)(4)在ISO5级(b)(4)腔体内进行生物素0.5 mg/mL（批号H17A05-26）灌装线组装，其头部、身体、袖管均处于腔体内，未同步开展人员微生物监测。

(2) On August 26, 2026, we observed Sterile Tech (b)(4) performing set up for the filling of Calcium Chloride (Lot #H24A01-26) with his sleeves inside the ISO 5 (b)(4), HEPA-filtered unidirectional airflow enclosure (LAFW-(b)(4)). The automated(b)(4) filling machine (b)(4) operates under (b)(4), HEPA-filtered unidirectional airflow enclosure with no physical barrier between the filling operation and the operator.

（2）2026年8月26日，我们观察到无菌技术人员(b)(4)在ISO5级(b)(4)高效过滤单向流罩（LAFW-(b)(4)）内开展氯化钙（批号H24A01-26）灌装组装，袖管置于单向流罩内部。该(b)(4)自动灌装机(b)(4)在(b)(4)高效过滤单向流罩下运行，灌装操作与操作人员之间无实体隔离屏障。

(C) Gloved fingertip monitoring of the Sterile Tech is performed only following completion of the aseptic filling production shift.

（C）无菌技术人员的手套指尖监测仅在无菌灌装生产班次全部结束后才实施。

OBSERVATION 2

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

公司未建立并执行旨在防止标示为无菌药品发生微生物污染的相关规程。

Specifically,

具体如下：

(A)Your firm has not adequately demonstrated that(b)(4)-sterilized machine (b)(4) parts and accessories used in aseptic filling maintain their sterile state during the established (b)(4) post-sterilization hold time in a controlled, non-classified area. The supporting microbiological evaluation consisted of swabbing part surfaces and incubating samples in (b)(4) medium at (b)(4).

（A）贵公司未能充分证明无菌灌装所用经(b)(4)灭菌的设备(b)(4)零部件及配件，在受控非分级区域内的既定(b)(4)灭菌后存放周期内可维持无菌状态。配套微生物评估仅对零部件表面进行擦拭取样，并置于(b)(4)培养基、(b)(4)条件下培养。

(1)Your firm has not provided adequate scientific justification that these incubation conditions are suitable for recovering and detecting microorganisms that may be encountered if the sterile barrier is compromised during storage within the non-classified area.

（1）贵公司未提供充分科学论证，证明该培养条件适用于回收、检出当无菌屏障在非分级区域存放期间破损时可能出现的微生物。

(2)The provided recorded associated with the sampling, in-house incubation, and results of the swab samples lacked the following critical information:

所提供的擦拭取样、内部培养及结果相关记录缺少以下关键信息：

①Actual incubation temperature

实际培养温度

②Date and time samples were placed in the incubator

样品放入培养箱的日期与时间

③Date and time samples were removed from the incubator

样品取出培养箱的日期与时间

④Identity of the person who read the results

读取结果人员身份

(3)According to your Senior Quality Manager and Senior Director of Compliance, following the in-house incubation of the swab samples, the samples were sent to your contract laboratory for sterility testing; however, the associated records, including the third-party sterility test results, could not be located.

（3）据贵公司高级质量经理与合规高级总监陈述，擦拭样品完成内部培养后，被送至合同实验室开展无菌检测；但是包括第三方无菌检测结果在内的相关记录无法找到。

(B)On August 21, 2026, during aseptic setup of the (b)(4) filling line for Biotin 0.5 mg/mL (Lot # H17A05-26), Chamber (b)(4) (Material Chamber) (b)(4) were (b)(4) exposing the (b)(4) surfaces to the ISO 7 environment. Subsequently the (b)(4) were (b)(4) without disinfecting the exposed (b)(4) surfaces, thereby reintroducing ISO 7 environmentally exposed surfaces into the ISO 5 critical area.

（B）2026年8月21日，在生物素0.5 mg/mL（批号H17A05-26）(b)(4)灌装线无菌组装期间，(b)(4)腔体（物料腔）(b)(4)发生(b)(4)，使(b)(4)表面暴露于ISO7级环境。后续在未对已暴露的(b)(4)表面进行消毒的情况下将(b)(4)(b)(4)，从而把已经接触ISO7环境的表面重新带入ISO5关键区域。

(C)Your firm has not adequately established a visual inspector qualification program to demonstrate that personnel can consistently and reliably detect microbial growth during the visual inspection of media-filled units.

（C）贵公司未充分建立目视检查员资质确认方案，无法证明人员在对培养基灌装样品进行目视检查时，能够稳定、可靠检出微生物生长。

(1)Your challenge qualification (b)(4), contain (b)(4) prepared with (b)(4) in (b)(4) vials and (b)(4). Your firm has no documented scientific justification for the use of (b)(4) a surrogate for actual microbial contamination/turbidity,.

（1）贵公司的挑战性确认样品(b)(4)内含使用(b)(4)制备的(b)(4)，装于(b)(4)西林瓶与(b)(4)中。贵公司无书面科学依据，证明使用(b)(4)替代真实微生物污染/浊度样品的合理性。

(2)There is no documented justification for the number, type, and distribution of positive units to demonstrate reliable contamination detection in media fills filled in (b)(4) vials.

（2）无书面依据说明阳性样品数量、类型与分布设置，无法证明在(b)(4)西林瓶培养基灌装中可实现可靠的污染检出。

(3)(b)(4) vials are used to simulate your (b)(4) mL and (b)(4) mL vialing process during aseptic process simulation (APS). You have not evaluated whether turbidity can be adequately detected in these vials.

（3）无菌工艺模拟试验（APS）使用(b)(4)西林瓶模拟(b)(4)mL、(b)(4)mL西林瓶灌装工艺。贵公司未评估在该类西林瓶中能否充分检出浊度。

(D)Your 2026 smoke studies, conducted as per PRO-029-01, Smoke Study Protocol, and PRO-029-03, (b)(4) Airflow Visualization Protocol, did not adequately qualify unidirectional airflow or demonstrate first air and acceptable airflow patterns during critical operations. For example:

（D）贵公司2026年气流烟雾试验依据PRO-029-01《烟雾试验方案》与PRO-029-03《(b)(4)气流可视化方案》开展，该试验未能充分确认单向流性能，无法证明关键操作期间一次流以及气流形态符合要求。例如：

(1)Airflow patterns could not be adequately assessed in multiple (b)(4) chambers and the (b)(4)-HEPA-filtered unidirectional airflow unit due to obstructions, glare, inadequate smoke introduction technique, and/or camera angle limitations (e.g. (b)(4) Chamber (b)(4) video; (b)(4) video).

（1）受遮挡、眩光、烟雾导入方式不当、摄像头角度限制等因素影响，多个(b)(4)腔体以及(b)(4)高效过滤单向流装置内气流形态无法充分评估（例如：(b)(4)腔体(b)(4)视频；(b)(4)视频）。

(2)In (b)(4) Chamber (b)(4) turbulent eddies were observed near a (b)(4) (video time point: ~3:26–4:22), and smoke was observed exiting and briefly re-entering the chamber near the top when the (b)(4) were (b)(4) during setup (video time point: ~4:40–4:55).

（2）在(b)(4)腔体(b)(4)内，在(b)(4)附近观察到湍流涡旋（视频时间点：3分26秒至4分22秒）；组装操作中(b)(4)(b)(4)时，烟雾从腔体顶部逸出并短暂回流入腔体（视频时间点：4分40秒至4分55秒）。

(3)The studies simulated routine activities, including line setup, loading of vials, stoppers and caps, and cleaning; however, the only corrective intervention evaluated was removal of a vial from the filling line using (b)(4). Your firm did not provide an adequate assessment demonstrating that the interventions selected represent reasonably foreseeable corrective interventions and worst-case aseptic manipulations during production. The affected equipment includes:

（3）该试验模拟常规操作，含灌装线组装、西林瓶/胶塞/铝盖上料以及清洁；但仅评估了使用(b)(4)从灌装线上取出西林瓶这一种纠正干预操作。贵公司未提供充分评估，证明所选干预操作代表生产过程中可合理预见的纠正操作以及最差情况无菌操作。受影响设备包括：

①(b)(4) in Suite (b)(4) housing the (b)(4) filling line used for sterile drug products such as Myer's Cocktail, NAD+ (β-Nicotinamide Adenine Dinucleotide) 100 mg/mL Injection, and MICC Injection.

(b)(4)洁净套间(b)(4)内的(b)(4)，配套用于生产迈尔混合注射液、β-烟酰胺腺嘌呤二核苷酸（NAD+）100 mg/mL注射液、MICC注射液等无菌药品的(b)(4)灌装线。

②(b)(4), HEPA-filtered unidirectional airflow enclosures (LAFW-(b)(4) LAFW-(b)(4)LAFW-(b)(4)) in Suite (b)(4), housing(b)(4) automated fillers(b)(4), and (b)(4) used for sterile drug products such as Niagen 100 mg/mL, Olympia Mineral Blend, and L-Taurine.

(b)(4)洁净套间(b)(4)内的(b)(4)高效过滤单向流罩（LAFW-(b)(4)、LAFW-(b)(4)、LAFW-(b)(4)），配套(b)(4)自动灌装机(b)(4)与(b)(4)，用于生产Niagen 100 mg/mL注射液、奥林匹亚矿物混合液、L-牛磺酸等无菌药品。

Your smoke study report, PRO-029-02, Smoke Study Protocol: FINAL REPORT (approved 02 June 2026), and RPT-PRO-029-03, (b)(4) Airflow Visualization Report (approved 07 August 2026), both concluded that the smoke studies successfully demonstrated unidirectional airflow during dynamic operations.

贵公司烟雾试验报告PRO-029-02《烟雾试验方案：最终报告》（2026年6月2日批准）以及RPT-PRO-029-03《(b)(4)气流可视化报告》（2026年8月7日批准）均得出结论：烟雾试验成功证明动态操作下单向流符合要求。

OBSERVATION 3

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.

在执行生产与工艺控制活动时，未遵守书面生产及工艺控制规程，也未在操作发生时同步记录。

Specifically,

具体如下：

(B) Batch record review of Myer's Cocktail (Lot # G27A05-26, Exp. 26 Nov 2026) revealed that equipment set-up of the (b)(4) filling line, located inside the ISO 5 (b)(4) in Suite (b)(4) began on 30 July 2026 at 08:01 and was completed by Sterile Tech (b)(4) at 08:06 — a total elapsed time of five minutes. However, set-up encompassed installation of (b)(4) chambers: (b)(4) where each require multiple set up steps. For example, the (b)(4) chamber alone required the installation of multiple components, including the (b)(4) and other associated parts.

（B）对迈尔混合注射液（批号G27A05-26，有效期至2026年11月26日）批记录审查发现，位于(b)(4)洁净套间ISO5级(b)(4)区域内的(b)(4)灌装线设备组装，2026年7月30日08:01启动，无菌技术人员(b)(4)于08:06完成，总耗时仅5分钟。但该组装工作包含(b)(4)个腔体的安装，每个腔体均有多步组装工序。举例而言，仅(b)(4)腔体就需要安装包含(b)(4)在内的多个组件及配套零件。

(C) Visual inspectors did not perform via(b)(4) as required by Section 9.3 of SOP-007, Visual Inspection of Sterile Drug Products, and inspection steps performed in practice differed from those written in the procedure.

（C）目视检查员未按照SOP-007《无菌药品目视检查规程》第9.3章节要求执行(b)(4)操作，实际执行的检查步骤与规程书面要求不一致。

(1) On August 20, 2026, Sterile Tech (b)(4) was observed conducting visual inspection of Amino Blend (Lot # H11A03-26) and failed to perform vial (b)(4). When subsequently asked to describe the inspection procedure, Sterile Tech (b)(4) was again unable to identify vial (b)(4) as a required step .

（1）2026年8月20日，观察到无菌技术人员(b)(4)对氨基酸混合液（批号H11A03-26）开展目视检查，未执行西林瓶(b)(4)操作。后续询问其描述检查规程时，该无菌技术人员仍无法识别西林瓶(b)(4)为规定必做步骤。

(2) On August 21, 2026, Sterile Tech (b)(4) was observed performing visual inspection of Biotin 0.5 mg/mL (Lot # H17A05-26) and similarly failed to perform vial (b)(4).

（2）2026年8月21日，观察到无菌技术人员(b)(4)对生物素0.5 mg/mL（批号H17A05-26）开展目视检查，同样未执行西林瓶(b)(4)操作。

(D) On September 1, 2026, the (b)(4) (Equipment ID: (b)(4) ) was observed loaded with (b)(4) on August 28, 2026. Notably, the (b)(4) was loaded with (b)(4) on (b)(4) (b)(4); however, your currently approved procedure, SOA-040-01, Sterilization Load Configurations, effective 05 June 2026, specifies a (b)(4) load pattern diagram of only (b)(4).

（D）2026年9月1日核查发现，(b)(4)设备（设备编号(b)(4)）在2026年8月28日装载了(b)(4)。值得注意的是，(b)(4)装载(b)(4)采用(b)(4)(b)(4)方式；但贵公司现行生效规程SOA-040-01《灭菌装载排布》（生效日期2026年6月5日）中规定的(b)(4)装载排布图仅为(b)(4)。

OBSERVATION 4

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

贵公司未能建立充分的书面生产与工艺控制规程，无法保证药品具备其标示的鉴别、效价、纯度与质量属性。

Specifically, the (b)(4) visual inspection qualification (b)(4) used to qualify personnel performing 100% visual inspection of injectable drug products are not adequately characterized or designed to challenge inspectors' ability to detect particulates at or near the threshold of visual detectability. For example:

具体如下：用于对注射剂100%目视检查人员进行资质确认的(b)(4)目视检查确认样品(b)(4)，未充分表征，样品设计不足以考核检查员检出处于目视检出阈值或接近阈值颗粒物的能力。例如：

(A) Your firm has not established the size or size range of the particulate defects contained in the qualification units intended to challenge visual inspectors to detect the smallest contaminants possible for an inspector with 20/20 vision. Although (b)(4) defect vials containing particulates were submitted for size characterization, the analysis was performed using the particle-size distribution method described in USP <429>, as documented in the Certificates of Analysis. The resulting data do not establish the size of the individual particulate defect contained in each qualification unit.

（A）贵公司未规定资质确认样品中颗粒物缺陷的尺寸或尺寸范围，该样品用于考核检查员检出20/20视力条件下可识别的最小污染物。虽然含有颗粒物的(b)(4)缺陷西林瓶提交了尺寸表征，并且按照分析报告记录采用USP<429>粒度分布方法开展分析，但所得数据无法确定每支确认样品中单个颗粒物缺陷的尺寸。

(B) No written procedures or records exist documenting the preparation and contents of each particulate defect unit, including particulate type, size or size range, and method of preparation. This information is known only to the individual who prepared the qualification (b)(4).

（B）无书面规程或记录，记载每支颗粒物缺陷样品的制备与内含物信息，包括颗粒物类型、尺寸/尺寸范围以及制备方法。该类信息仅制备该确认样品(b)(4)的人员知晓。

OBSERVATION 5

The written stability program for drug products does not include reliable, meaningful and specific test methods.

药品书面稳定性方案未包含可靠、有效且专属的检测方法。

Specifically, your firm assigns a (b)(4) beyond-use date (BUD) to Sermorelin Acetate 0.9 mg/mL Injection based on your contract laboratory stability study. However, your firm failed to provide adequate demonstration that the analytical procedure can detect relevant degradation-related changes. Your method validation report for Sermorelin Acetate, approved on August 22, 2025, does not include a mass balance assessment to demonstrate that the analytical method can adequately account for the drug substance and its degradation products, supporting the method's stability-indicating capability and reliability.

具体如下：贵公司依据合同实验室的稳定性研究，为醋酸舍莫瑞林0.9 mg/mL注射液设定(b)(4)使用期限（BUD）。但贵公司未能充分证明该分析方法可以检出相关降解变化。醋酸舍莫瑞林方法验证报告于2025年8月22日批准，报告未开展质量平衡评估，无法证明该分析方法能够充分定量原料药及其降解产物，不足以佐证方法具备稳定性指示能力与可靠性。

OBSERVATION 6

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

用于防止药品无菌工艺操作发生污染与混淆的独立/划定区域存在缺陷。

Specifically,

具体如下：

(A) Your firm utilizes (b)(4) QA-access-controlled cabinets for the storage of sterilized machine(b)(4) parts and accessories. (b)(4). During inspection of these cabinets(b)(4) components, including a stopper bowl that directly contacts product stoppers, were observed without sterilization-status labels. The components lacked information identifying the applicable (b)(4) and sterilization date needed for personnel to determine whether the established sterile hold time had been exceeded.

（A）贵公司使用(b)(4) QA权限管控储物柜存放灭菌后的设备(b)(4)零部件与配件，(b)(4)。检查这些储物柜时发现，包含直接接触产品胶塞的胶塞料斗在内的(b)(4)零部件无灭菌状态标签。零部件缺少(b)(4)编号与灭菌日期信息，操作人员无法判断是否超出既定无菌存放时限。

(B) Sterilization-status labels are generated by operators; however, the firm did not demonstrate a system for reconciling generated labels to the individual equipment parts associated with each sterilization cycle.

（B）灭菌状态标签由操作员打印生成；但公司未能证明存在一套体系，可将打印标签与对应每个灭菌周期的单件设备零部件进行核对追溯。

OBSERVATION 7

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

物料检验存在缺陷，各类物料未按照全部适用书面质量标准开展纯度、效价与质量符合性检验。

Specifically,

具体如下：

(A) SOP-035, Procurement, Receipt, and Inspection of Incoming Components and Materials, does not include a sampling plan specifying the number of containers to be sampled per shipment. According to the Senior Supply Chain Manager, (b)(4) sent from your (b)(4) warehouse to your facility for sampling. Additionally, no documentation exists for the sampling performed.

（A）SOP-035《物料采购、接收与进厂检验》未包含取样方案，未规定每批到货需取样的容器数量。据高级供应链经理陈述，从贵公司(b)(4)仓库发送(b)(4)至生产场地取样。同时，无取样操作相关记录。

(B) Your firm failed to perform a specific identity test that includes a methanol limit test on each container of each lot of ethyl alcohol used as a pharmaceutical ingredient. On May 12, 2025, your firm received (b)(4) bottles of (b)(4) Ethyl Alcohol (b)(4) Proof (Batch #(b)(4) ); (b)(4) sampled, and methanol limit testing was not performed. This lot was used in the production of T-105 Injection (Papaverine Hydrochloride 30 mg/mL; Phentolamine Mesylate 1 mg/mL; Alprostadil 0.01 mg/mL), Lot #G08A10-26, BUD 04 JUL 2027.

（B）贵公司未对作为药用辅料的每一批乙醇的每个容器开展包含甲醇限度检查在内的专属鉴别试验。2025年5月12日，贵公司收到(b)(4)瓶(b)(4)度乙醇（批号(b)(4)）；仅取样(b)(4)份，未开展甲醇限度检测。该批次物料用于生产T-105注射液（盐酸罂粟碱30 mg/mL；甲磺酸酚妥拉明1 mg/mL；前列地尔0.01 mg/mL），批号G08A10-26，使用期限至2027年7月4日。

(C) Your firm failed to test each container of each lot of glycerin, used as a pharmaceutical ingredient, for diethylene glycol (DEG) or ethylene glycol (EG) contamination. Your firm did not provide a scientifically sound justification, supported by statistical analysis, for reduced sampling. On September 25, 2025, your firm received (b)(4) bottles of(b)(4) Glycerin, NF (b)(4) ((b)(4) ) (Lot #(b)(4) ); however, (b)(4) sampled and tested for this shipment. Additionally, Lot # (b)(4) was tested only for Identification A and was not tested for DEG and EG prior to release for use. This lot was used in the production of Glycerin 48% / Lidocaine 0.33% Injection (Lot #E20A10-26; BUD 10 JAN 2027).

（C）贵公司未对作为药用辅料的每一批甘油的每个容器开展二甘醇（DEG）、乙二醇（EG）污染检测。贵公司未提供经统计学分析支撑的科学依据证明可减少取样量。2025年9月25日，贵公司收到(b)(4)瓶NF级(b)(4)甘油（(b)(4)）（批号(b)(4)）；但该到货批次仅取样(b)(4)检验。另外，批号(b)(4)仅做鉴别A项检验，放行使用前未检测二甘醇与乙二醇。该批次用于生产48%甘油/0.33%利多卡因注射液（批号E20A10-26；使用期限至2027年1月10日）。

OBSERVATION 8

Each component is not added to the batch by one person and verified by a second person..

投料操作未执行一人投料、第二人复核的双人复核要求。

Specifically, a review of the batch record for Myer's Cocktail (Lot #(b)(4), Exp (b)(4)) revealed that ingredients were added between (b)(4) on July 29, 2026, with no documented contemporaneous verification recorded after each individual addition. Instead, a single verification timestamp of (b)(4) was documented for this manufacturing step, more than two hours after the last ingredient was added.

具体如下：对迈尔混合注射液（批号(b)(4)，有效期(b)(4)）批记录审查发现，原料于2026年7月29日(b)(4)时段投料，每一次投料后均无同步复核记录。该生产步骤仅记录了单一复核时间戳(b)(4)，该记录在最后一项原料投料完成超过2小时之后才填写。