# FDA 483 - Akron Coating & Adhesives Inc - April 10, 2019

Source: https://www.keypedia.com/records/483/akron-coating-adhesives-inc/37e3f826-42ad-49eb-98a9-871fafc064b9

> FDA 483 for Akron Coating & Adhesives Inc on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akron Coating & Adhesives Inc
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Akron Coating & Adhesives Inc in Akron, OH, from April 3-10, 2019, revealed significant deficiencies in their manufacturing processes for drug products. The firm failed to adequately verify component identity, establish appropriate expiration dates, maintain a written stability testing program, and follow existing stability protocols. Additionally, issues with process validation and preventing cross-contamination between GMP and non-GMP products were noted, indicating a lack of control over drug product quality and purity.

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## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

Company: https://www.keypedia.com/companies/akron-coating-adhesives-inc/5c4d19a2-1774-4e2b-b433-3afa5b597b11

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22