# FDA 483 - Nang Kuang Pharmaceutical Co., Ltd. - April 02, 2024

Source: https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/6b9c88e6-c875-4643-8e4f-2b1f58682854

> FDA 483 for Nang Kuang Pharmaceutical Co., Ltd. on April 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nang Kuang Pharmaceutical Co., Ltd.
- Inspection Date: 2024-04-02
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Nang Kuang Pharmaceutical Co., Ltd. in Tainan City, Taiwan, was inspected by the FDA, revealing significant deficiencies across multiple areas. The inspection found issues with drug product container integrity, inadequate investigations into discrepancies, and compromised laboratory and environmental controls. These observations indicate a lack of robust quality systems, potentially impacting drug product safety, identity, strength, quality, and purity.

## Related Documents

- [483 - 2022-06-16](https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/410c947e-d092-4b4a-ae12-09e56bb846ef)
- [483 - 2024-11-07](https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/cc1bb01f-3203-420d-a211-395f7f389f5e)

## Related Officers

- [investigator](https://www.keypedia.com/people/amir-alavi/d7179128-eb3f-489e-97cf-e2c5e5539a00)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/nang-kuang-pharmaceutical-co-ltd/bdb8b0bb-4a8d-4f50-a72d-e250626e2818

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8