# FDA 483 - Cornerstone Laboratories LLC - January 19, 2023

Source: https://www.globalkeysolutions.net/records/483/cornerstone-laboratories-llc/68da53e3-c4b3-4e08-a581-657839e4c55e

> FDA 483 for Cornerstone Laboratories LLC on January 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cornerstone Laboratories LLC
- Inspection Date: 2023-01-19
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Cornerstone Laboratories LLC, a contract testing lab in Memphis, TN, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality control unit, laboratory records, computer system controls, employee training, and instrument calibration, indicating a systemic lack of written procedures and proper oversight for critical operations. These issues collectively point to a serious breakdown in cGMP compliance, particularly concerning data integrity and quality assurance for OTC drug product testing.

## Related Officers

- [Medical Officer at FDA](https://www.globalkeysolutions.net/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)
- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)

Company: https://www.globalkeysolutions.net/companies/cornerstone-laboratories-llc/ef78bab1-e800-4bcf-971c-24a6bb04f115

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea