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

Source: https://www.globalkeysolutions.net/records/483/cosmetic-specialty-labs-inc/cd7e5ac3-8222-478c-9f29-e7f008f4ef11

> 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 inspected and cited for multiple deficiencies in its quality control and manufacturing processes. Observations included inadequate microbiological testing, deficient water system monitoring, lack of stability testing programs, unvalidated manufacturing processes, and insufficient complaint handling and annual product review procedures. These issues indicate a general lack of robust quality systems for their non-sterile topical 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/158d1290-8cf9-406b-85c0-4c52c2039ca8)
- [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