# FDA 483 - Nang Kuang Pharmaceutical Co., Ltd. - November 07, 2024

Source: https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/cc1bb01f-3203-420d-a211-395f7f389f5e

> FDA 483 for Nang Kuang Pharmaceutical Co., Ltd. on November 07, 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: 2024-11-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Nang Kuang Pharmaceutical Co. in Tainan City, Taiwan, was cited for significant deficiencies across its drug product manufacturing operations. Observations included inadequate production and process controls, widespread failures in preventing microbiological contamination of sterile products, and a deficient visual inspection program. The inspection also highlighted issues with laboratory controls, environmental monitoring, cleaning and sanitization, and overall Quality Unit oversight, indicating a systemic lack of control over critical GMP processes.

## Related Documents

- [483 - 2022-06-16](https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/410c947e-d092-4b4a-ae12-09e56bb846ef)
- [483 - 2024-04-02](https://www.keypedia.com/records/483/nang-kuang-pharmaceutical-co-ltd/6b9c88e6-c875-4643-8e4f-2b1f58682854)

## Related Officers

- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Pharmaceutical Scientist](https://www.keypedia.com/people/mia-j-chang/3d26c94d-9fd5-4b5a-9cfb-72323d3db969)
- [Karthik M. Krishnan](https://www.keypedia.com/people/karthik-m-krishnan/5ded6b7c-ef26-4a5f-b823-4eb017617d7c)
- [Liqun Zhao](https://www.keypedia.com/people/liqun-zhao/6fdfb753-7788-4351-9b0b-65e06c201bc5)

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