# FDA 483 - Mentholatum (China) Pharmaceuticals Co., Ltd. - June 21, 2019

Source: https://www.keypedia.com/records/483/mentholatum-china-pharmaceuticals-co-ltd/c6230b07-ca0e-408b-a880-ccedbabc8711

> FDA 483 for Mentholatum (China) Pharmaceuticals Co., Ltd. on June 21, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mentholatum (China) Pharmaceuticals Co., Ltd.
- Inspection Date: 2019-06-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Mentholatum (China) Pharmaceuticals Co., Ltd. in Zhongshan, China, a drug manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate laboratory controls, specifically concerning method verification for an assay, and a failure to thoroughly review unexplained discrepancies. These issues indicate deficiencies in quality control and assurance processes.

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Company: https://www.keypedia.com/companies/mentholatum-china-pharmaceuticals-co-ltd/2b8f0a01-6d99-47ab-a702-fe28c28e96f4

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