# FDA 483 - Guangxi Yulin Pharmaceutical Group Co. Ltd. - March 21, 2025

Source: https://www.keypedia.com/records/483/guangxi-yulin-pharmaceutical-group-co-ltd/5c329ca0-cc1d-4df7-b776-7e4693ad5b7f

> FDA 483 for Guangxi Yulin Pharmaceutical Group Co. Ltd. on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guangxi Yulin Pharmaceutical Group Co. Ltd.
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Guangxi Yulin Pharmaceutical Group Co. Ltd. in Yulin, China, was inspected by the FDA from March 17-21, 2025, for its OTC drug manufacturing operations. The inspection revealed significant deficiencies across multiple areas, including inadequate laboratory controls, unvalidated test methods, and a lack of stability testing programs. These issues indicate a severe lack of adherence to cGMP requirements, potentially impacting the identity, strength, quality, and purity of drug products distributed to the U.S. market.

## Related Documents

- [WARNING_LETTER - 2025-03-21](https://www.keypedia.com/records/warning_letter/guangxi-yulin-pharmaceutical-group-co-ltd/87d84374-5040-4430-a8c7-a435768ffa74)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)
- [Crystal Monroy](https://www.keypedia.com/people/crystal-monroy/b0414886-fb71-4f35-a453-0ad2baf13bfc)

Company: https://www.keypedia.com/companies/guangxi-yulin-pharmaceutical-group-co-ltd/3815cb2a-39f8-4338-9e21-e6dcd7f7a015

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