FDA Inspection
Akron Coating & Adhesives IncAkron Coating & Adhesives Inc – FDA Inspection, Aug 4, 2026
Record Details
This FDA Inspection record concerns Akron Coating & Adhesives Inc, with an inspection on August 4, 2026, issued by the Cincinnati District Office, covering human drugs.
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ID · e3213e4e-aef2-4884-bb99-9ffd2122696f
Inspection Facts
- Inspection number
- 1331754
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.130(a)Prevention of cross contamination, mix-ups
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Akron Coating & Adhesives Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 4, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 2, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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