01.04.2026
[中譯] 2026年4月1日

FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
[中譯] FDA 警告信：從裝有分析紀錄的垃圾袋到預先簽署與倒填日期之數據

The FDA has issued a new Warning Letter dated 03 March 2026, flagging systemic data integrity and quality failures at an Indian contract testing laboratory.
[中譯] FDA 已發布一份日期為 2026 年 3 月 3 日的新警告信，指出一家印度委託檢驗實驗室存在系統性資料完整性與品質體系失效。

Data Integrity
[中譯] 資料完整性

At the center of the findings is a fundamental breakdown in data governance.
[中譯] 此次發現的核心在於數據治理體系的根本性崩潰。

The Warning Letter states that the "investigator discovered two garbage bags containing torn analytical records, including chromatographic results, unidentified number lists, and impurity method validation spreadsheets with handwritten notes. For the method validation study, official records contained only handwritten values, while the original data was discarded in the garbage bags. [...] Additionally, laboratory staff used unofficial personal diaries to record procedures, analytical observations, results, method modifications, and deviation descriptions."
[中譯] 警告信指出，「檢查員發現了兩袋裝有撕毀分析紀錄的垃圾袋，其中包括層析結果、未識別的數字清單以及帶有手寫註釋的雜質分析方法確效試算表。在方法確效研究中，正式紀錄僅包含手寫數值，而原始數據卻被丟棄在垃圾袋中。[...] 此外，實驗室人員使用非正式的個人日誌來記錄操作程序、分析觀察、結果、方法變更以及偏差描述。」

The company argued that the validation documents in the garbage bags were not related to drug products destined for the United States.
[中譯] 該公司辯稱垃圾袋中的確效文件與運往美國的藥品無關。

However, the FDA makes clear that such practices eliminate traceability and raise serious doubts about the reliability of all data generated at the site, independent of the intended market.
[中譯] 然而，FDA 明確指出，此類行為消除了可追溯性，並對該廠址產生的所有數據可靠性產生嚴重懷疑，無論其預定市場為何。

Laboratory Deviations and Unexplained Out-of-Specification (OOS) Results
[中譯] 實驗室偏差與未經解釋之檢驗超標 (OOS) 結果

The FDA found that an unofficial audit form was used to document laboratory deficiencies, "including a discrepancy in which microbiological sample plates could not be located in an incubator despite a logbook entry indicating the plates had been placed there."
[中譯] FDA 發現廠方使用非正式的稽核表單來記錄實驗室缺陷，「其中包括一項差異：儘管日誌紀錄顯示微生物培養皿已放入培養箱，但在培養箱中卻找不到該檢體培養皿。」

Further deficiencies were identified in OOS and deviation handling. The firm reissued passing test results without any documented investigation after initial out-of-specification findings, and deviations were handled outside the formal quality system without CAPA tracking.
[中譯] 在 OOS 與偏差處理方面也發現了進一步的缺失。該公司在出現初步檢驗超標發現後，在未進行任何書面調查的情況下重新發布合格結果，且偏差處理脫離了正式品質體系，缺乏 CAPA 追蹤。

The company’s argument that certain tests were conducted “for informational purposes only” was explicitly rejected by the FDA, which reiterated that all testing activities must comply with CGMP requirements.
[中譯] 該公司辯稱某些測試「僅供參考用途」，此說法遭 FDA 明確拒絕，並重申所有檢測活動均須符合 CGMP 要求。

Documentation Practices
[中譯] 文件紀錄規範

In addition, the FDA observed non-contemporaneous and manipulated documentation practices, including pre-signed maintenance records and backdated analytical data.
[中譯] 此外，FDA 觀察到非同步且涉及人為操作的文件紀錄行為，包含預先簽署維護紀錄以及倒填分析數據日期。

Notably, these issues had been cited in previous inspections, reinforcing FDA’s view that the deficiencies are systemic rather than isolated.
[中譯] 值得注意的是，這些問題在先前的檢查中就曾被提及，這強化了 FDA 的觀點，即這些缺陷是系統性的而非個別事件。

The situation is further aggravated by inspection obstruction. The FDA writes: "Your firm limited access to records requested during the inspection. At the initiation of the inspection, our investigator observed your firm attempting to remove two large garbage bags later determined to contain analytical documents. Other documents that had been removed from the quality control laboratory were requested but were not provided to our investigator."
[中譯] 阻礙檢查的行為使情況進一步惡化。FDA 寫道：「貴公司限制了對檢查期間所要求紀錄的存取。在檢查開始時，我們的檢查員觀察到貴公司試圖移除兩大袋垃圾袋，隨後確認其中含有分析文件。其他從品管實驗室移走的紀錄雖經要求，但仍未提供給我們的檢查員。」

To see the complete list of observations, please refer to the full Warning Letter to Tentamus India Private Limited published on the FDA’s website.
[中譯] 欲查閱完整的觀察項清單，請參閱 FDA 網站上發布的 Tentamus India Private Limited 完整警告信。

Source: https://www.gmp-compliance.org/gmp-news/fda-warning-letter-from-garbage-bags-with-analytical-records-to-pre-signed-and-backdated-data
[中譯] 來源：https://www.gmp-compliance.org/gmp-news/fda-warning-letter-from-garbage-bags-with-analytical-records-to-pre-signed-and-backdated-data