# FDA 483 - Hangzhou Facecare Cosmetics Co., Ltd. - April 05, 2019

Source: https://www.keypedia.com/records/483/hangzhou-facecare-cosmetics-co-ltd/9fc0aee4-a407-4e7b-b89d-d170c0537770

> FDA 483 for Hangzhou Facecare Cosmetics Co., Ltd. on April 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Facecare Cosmetics Co., Ltd.
- Inspection Date: 2019-04-05
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hangzhou FaceCare Cosmetics Co. Ltd., an OTC drug manufacturer in Hangzhou, China, was cited for ten observations during an FDA inspection. The observations primarily concern deficiencies in quality control, record-keeping, and validation procedures across various aspects of manufacturing, including material identification, equipment calibration, sampling, cleaning, testing methods, and supplier qualification. These issues indicate a lack of robust control over critical manufacturing processes and documentation.

## Related Documents

- [483 - 2017-06-19](https://www.keypedia.com/records/483/hangzhou-facecare-cosmetics-co-ltd/f02694e2-fe70-48b7-a0f5-4197ea0c6c6d)
- [WARNING_LETTER - 2017-06-22](https://www.keypedia.com/records/warning_letter/hangzhou-facecare-cosmetics-co-ltd/8eecae36-b8c9-465d-810b-c1b4a8dd291b)

## Related Officers

- [Wilmary Negron Rodriguez](https://www.keypedia.com/people/wilmary-negron-rodriguez/e7bb04eb-ed58-4e4c-932d-1069c76c0215)

Company: https://www.keypedia.com/companies/hangzhou-facecare-cosmetics-co-ltd/caeaa010-09c9-4b80-99ae-9b9b1f674a60

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