# FDA 483 - Cosmetic Specialty Labs, Inc - November 18, 2013

Source: https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/158d1290-8cf9-406b-85c0-4c52c2039ca8

> FDA 483 for Cosmetic Specialty Labs, Inc on November 18, 2013. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cosmetic Specialty Labs, Inc
- Inspection Date: 2013-11-18
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Cosmetic Specialty Labs, Inc. in Lawton, OK, a drug manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes during an FDA inspection. The observations highlight a lack of appropriate laboratory testing, inadequate procedures for preventing objectionable microorganisms, and an absence of validated processes and stability programs for its non-sterile drug products. These issues indicate a failure to ensure the identity, strength, quality, and purity of its 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 - 2023-09-20](https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/2523b7eb-777e-4057-9022-387939870f5c)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/elizabeth-d-connell/085f2b40-dcf8-40ad-ba33-d0970228768b)

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

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9