# FDA 483 - Acme United Corporation - March 28, 2025

Source: https://www.globalkeysolutions.net/records/483/acme-united-corporation/096890ef-52ee-4ac9-a7ee-268eb5eee4f9

> FDA 483 for Acme United Corporation on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acme United Corporation
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Acme United Corporation received a Form 483 citing significant deficiencies in quality control, manufacturing processes, and facility maintenance. The firm failed to conduct thorough investigations into out-of-specification results, lacked adequate testing and validation for its drug products and equipment, and demonstrated poor control over computer systems and equipment identification. These issues indicate a systemic breakdown in ensuring product quality and compliance with cGMP regulations.

## Related Documents

- [483 - 2017-05-26](https://www.globalkeysolutions.net/records/483/acme-united-corporation/31aca045-8020-4240-a64b-9bfb33da4e07)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

Company: https://www.globalkeysolutions.net/companies/acme-united-corporation/89eaa736-efa8-4e67-9368-dd46da7f55b0

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9