# FDA 483 - COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. - March 15, 2023

Source: https://www.keypedia.com/records/483/cosmobeauti-laboratories-manufacturing-inc/167431d5-e5d3-48cb-a4b0-cc3c24998b87

> FDA 483 for COSMOBEAUTI LABORATORIES & MANUFACTURING, INC. on March 15, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.
- Inspection Date: 2023-03-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: COSMOBEAUTI LABORATORIES & MANUFACTURING, INC., a contract drug manufacturer in San Dimas, CA, was cited for numerous significant Good Manufacturing Practice (GMP) deficiencies during an FDA inspection. The inspection revealed repeat observations from a previous inspection, highlighting systemic failures in batch recordkeeping, quality unit oversight, investigation of discrepancies, stability testing, component control, process validation, and facility sanitation. These issues indicate a severe lack of control over drug product manufacturing and quality assurance for sunscreens and hand sanitizers.

## Related Officers

- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/cosmobeauti-laboratories-manufacturing-inc/3256eea7-f336-4adc-a256-566b34907efb

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