# FDA 483 - Akron Coating & Adhesives Inc - June 27, 2022

Source: https://www.keypedia.com/records/483/akron-coating-adhesives-inc/2141747f-6c22-4855-9bcb-0d112cca09bd

> FDA 483 for Akron Coating & Adhesives Inc on June 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Akron Coating & Adhesives Inc
- Inspection Date: 2022-06-27
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Akron Coating & Adhesives Inc. in Akron, OH, revealed multiple significant deficiencies in their manufacturing and quality control systems for drug products. Key issues included inadequate stability testing, insufficient laboratory controls, and a lack of proper process validation and equipment calibration. The firm also failed to perform microbiological testing on non-sterile products and exhibited poor adherence to quality control unit procedures, including change control and deviation management.

## Related Documents

- [483 - 2019-04-10](https://www.keypedia.com/records/483/akron-coating-adhesives-inc/37e3f826-42ad-49eb-98a9-871fafc064b9)

## Related Officers

- [Brent M. Dehaan](https://www.keypedia.com/people/brent-m-dehaan/7a6af4a2-2566-48af-b59d-dd59008ff997)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

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