# FDA WARNING_LETTER - Nan San (HK) Pharmaceutical Factory Ltd. - September 29, 2017

Source: https://www.globalkeysolutions.net/records/warning_letter/nan-san-hk-pharmaceutical-factory-ltd/b0f9661f-0ee1-4bf1-b406-c19cbfd7202d

> FDA WARNING_LETTER for Nan San (HK) Pharmaceutical Factory Ltd. on September 29, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nan San (HK) Pharmaceutical Factory Ltd.
- Inspection Date: 2017-09-29
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Nan San (HK) Pharmaceutical Factory Ltd. following a September 25-29, 2017 inspection, citing significant CGMP violations and misbranded drug products. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key CGMP violations include:
1.  **Failure to test drug products prior to release (21 CFR 211.165(a) and (b))**: The firm did not perform microbial limit tests for all batches of OTC topical liquid analgesics (e.g., Easy-Flex) and relied on a contract laboratory that only tested one of multiple active ingredients.
2.  **Lack of written production and process control procedures (21 CFR 211.100(a))**: The firm has not validated manufacturing processes for OTC drug products and lacks an ongoing process control monitoring program.
3.  **Failure to test components for identity (21 CFR 211.84(d)(1))**: Incoming active pharmaceutical ingredients and other components were not tested for identity, purity, strength, and quality before use.
4.  **Inadequate stability testing program (21 CFR 211.166(a))**: The firm assigned a 3-year expiration date without sufficient stability data.

The firm'

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Company: https://www.globalkeysolutions.net/companies/nan-san-hk-pharmaceutical-factory-ltd/d8f1d5c8-43eb-4a3b-a7fb-faae9b70dfc1

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c