# FDA 483 - Dee Cee Laboratories, Inc - September 13, 2019

Source: https://www.keypedia.com/records/483/dee-cee-laboratories-inc/0cecc2e0-c82e-4de7-a936-9f559f1458d3

> FDA 483 for Dee Cee Laboratories, Inc on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dee Cee Laboratories, Inc
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Dee Cee Laboratories, Inc. in White House, TN, revealed significant deficiencies in their manufacturing and quality control processes for OTC drug products. The firm failed to validate manufacturing processes, investigate batch failures and customer complaints, and conduct adequate finished product and in-process testing. These observations indicate a lack of robust quality systems necessary to ensure drug product identity, strength, quality, and purity.

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/dee-cee-laboratories-inc/e52daabf-8f5a-4dc4-a33b-9d3a24e7e667

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7