# FDA 483 - Cosmetic Specialty Labs, Inc - September 20, 2023

Source: https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/2523b7eb-777e-4057-9022-387939870f5c

> FDA 483 for Cosmetic Specialty Labs, Inc on September 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Specialty Labs, Inc
- Inspection Date: 2023-09-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Cosmetic Specialty Labs, Inc., a contract drug manufacturer in Lawton, OK, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to adhere to quality control unit responsibilities, lacked process validation and stability testing programs, and exhibited inadequate laboratory controls and equipment cleaning procedures. These issues indicate a systemic failure to ensure the quality, purity, and safety of their OTC drug products.

## Related Documents

- [483 - 2010-09-22](https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/d5a26932-3114-401c-8354-72c6bf969917)
- [483 - 2013-11-18](https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/cd7e5ac3-8222-478c-9f29-e7f008f4ef11)
- [483 - 2013-11-18](https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/158d1290-8cf9-406b-85c0-4c52c2039ca8)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shanna-n-purdy/7a677cf5-484f-4e9a-91b1-27398411ff32)

Company: https://www.globalkeysolutions.net/companies/cosmetic-specialty-labs-inc/4a3bbfb4-f354-4e70-adef-c51624a3c1c4

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab