# FDA 483 - Cosmaceutical Research Lab Inc. - June 10, 2022

Source: https://www.globalkeysolutions.net/records/483/cosmaceutical-research-lab-inc/98743c4c-1157-41b6-8033-0db4bca5c010

> FDA 483 for Cosmaceutical Research Lab Inc. on June 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmaceutical Research Lab Inc.
- Inspection Date: 2022-06-10
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Cosmaceutical Research Lab Inc. in Surrey, a drug manufacturer, revealed significant deficiencies in laboratory controls, investigation procedures, and quality control unit responsibilities. The firm failed to establish adequate microbiological testing methods, properly investigate out-of-specification events and product failures, and maintain appropriate quality control practices including data integrity and equipment cleanliness. These observations indicate a lack of robust quality systems for their OTC drug products.

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## Related Officers

- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.globalkeysolutions.net/companies/cosmaceutical-research-lab-inc/3713d087-c229-4b81-86b4-da71d519c6c0

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552