FDA Inspection 682115 — American Health Packaging
The FDA completed an inspection of American Health Packaging on July 16, 2010 in Columbus, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 16, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1498 | 21 CFR 211.122(b) | Labeling and packaging improperly approved/released |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |