FDA Inspection 1085825 — Akron Coating & Adhesives Inc
The FDA completed an inspection of Akron Coating & Adhesives Inc on April 10, 2019 in Akron, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Akron, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |