# FDA 483 - Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory - June 18, 2015

Source: https://www.keypedia.com/records/483/zhejiang-medicine-co-ltd-xinchang-pharmaceutical-factory/56458423-b281-4593-9ae2-cbdef29b8eb0

> FDA 483 for Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory on June 18, 2015. Product: Cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory
- Inspection Date: 2015-06-18
- Product Type: Cosmetics
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA Form 483 details multiple significant deviations observed during an inspection of a firm's manufacturing and quality control operations.

**Laboratory Control and Data Integrity Issues:**
*   **Pre-testing and Data Discarding:** The firm's Quality Control laboratory was found to pre-test samples multiple times using electronic chromatography, saving trial data in auxiliary R&D folders. Raw data (e.g., sample weight/dilutions) for these trial analyses were discarded. Historical data for residual solvent by GC testing of API showed potential significant differences between trial and official results, including unknown peaks, which could indicate out-of-specification batches. Lack of supporting raw data prevented accurate calculation of residual solvent levels.
*   **Non-Contemporaneous Documentation:** QC laboratory records were not documented contemporaneously. Examples include:
    *   A QC analyst pasting balance weighing slips generated on June 11, 2015, onto a worksheet on June 15, 2015, and backdating the signature to June 11, 2015.
    *   An analyst performing a calculation for HPLC analysis on June 15, 2015, based on data from June 10, 2015, with the blank calculation page pre-signed and dated June 10, 2015.
    *   An analyst signing a microbiology testing report on June 17

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