# FDA 483 - COSMETIC LABORATORY INC - August 03, 2022

Source: https://www.globalkeysolutions.net/records/483/cosmetic-laboratory-inc/0cd75eb5-4254-4464-bbfc-0ae76c6aa504

> FDA 483 for COSMETIC LABORATORY INC on August 03, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: COSMETIC LABORATORY INC
- Inspection Date: 2022-08-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Cosmetic Lab, Inc. in Downey, CA, a contract manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products like hand sanitizer and SPF. The inspection revealed issues with component identity testing, lack of process and equipment validation, inadequate cleaning validation, and insufficient vendor qualification. Additionally, annual product reviews lacked necessary detail for quality evaluation.

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.globalkeysolutions.net/companies/cosmetic-laboratory-inc/f3977335-f446-489a-be98-aa03c573776b

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6