# FDA 483 - Xiamen LP Pharmaceutical Co., Ltd. - March 04, 2022

Source: https://www.keypedia.com/records/483/xiamen-lp-pharmaceutical-co-ltd/595e588f-4cc5-402f-87ad-54fa29bbf051

> FDA 483 for Xiamen LP Pharmaceutical Co., Ltd. on March 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xiamen LP Pharmaceutical Co., Ltd.
- Inspection Date: 2022-03-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Xiamen LP Pharmaceutical Co., Ltd, a drug manufacturer in Xiamen, China, received two observations during an FDA inspection. The firm was cited for failing to follow its written procedures for equipment calibration and for having a deficient supplier management program. These issues indicate a lack of adherence to established quality control practices for manufacturing and supplier oversight.

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.keypedia.com/companies/xiamen-lp-pharmaceutical-co-ltd/fb23c997-3591-4cab-a4f2-17802b76cb23

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1