FDA Inspection 1173157 — Akron Coating & Adhesives Inc
The FDA completed an inspection of Akron Coating & Adhesives Inc on June 27, 2022 in Akron, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Akron, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |