# FDA 483 - NATCO Pharma Limited - January 24, 2017

Source: https://www.keypedia.com/records/483/natco-pharma-limited/2a205475-5923-4695-9193-3ade2ddbebb2

> FDA 483 for NATCO Pharma Limited on January 24, 2017. Product: Cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NATCO Pharma Limited
- Inspection Date: 2017-01-24
- Product Type: Cosmetics
- Office Name: Center for Biologics Evaluation and Research
- Summary: This FDA Form 483 document details observations from an inspection, highlighting deficiencies in the facility's quality control unit, stability testing program, laboratory controls, and field alert reporting.

**Quality Control Unit Deficiencies:**
*   **Inadequate Complaint Investigations:** Complaint N/IV/MC/15/016 (lack of effectiveness of (b)(4) mg capsules) lacked assay of returned or retention samples. Complaint N/IV/MC/15/009 (lack of effectiveness of (b)(4) mg tablets) was unsubstantiated due to unavailable lot number, with no documented attempts to obtain the sample as per SOP IVQA/001-06.
*   **Untimely Incident Investigations:** Stability sample incidents were not closed within the (b)(4) working days required by SOP SQA/01-02.
*   **Failure to Initiate CAPAs:** No CAPAs were initiated for repeated incidents of 227 stability samples tested outside their timeframe, market complaint N/IV/MC/16/027 (incorrect barcode labels), or laboratory investigations N/V/005/15/006 and N/V/005/15/035 (dirty septa/vials).
*   **Untimely Complaint Investigations:** Complaint N/IV/MC/15/030 was not finalized within the (b)(

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## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
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Company: https://www.keypedia.com/companies/natco-pharma-limited/4c97e2d8-0023-4572-966f-d396e8fecc05

Office: https://www.keypedia.com/offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d