# FDA 483 - PL Cosmetic - July 01, 2022

Source: https://www.keypedia.com/records/483/pl-cosmetic/51edf38e-ef6a-40f5-9c17-e1f0f50f3b29

> FDA 483 for PL Cosmetic on July 01, 2022. Product: cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PL Cosmetic
- Inspection Date: 2022-07-01
- Product Type: cosmetics
- Office Name: Office of Biological Products Operations - Division I
- Summary: PL Cosmetic, a manufacturer in Namdong, Korea, was cited for significant deficiencies in its laboratory and production systems. The inspection revealed issues including falsified stability data, inadequate laboratory controls for electronic records and equipment, and a lack of scientifically sound sampling plans. Additionally, the firm failed to conduct annual visual examinations of reserve samples and lacked written procedures for validating and controlling manufacturing processes.

## Related Officers

- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/pl-cosmetic/e5d157de-7228-47b3-9ab6-29873473b1dc

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