FDA Inspection 715478 — Apex International Mfg., LLC
The FDA completed an inspection of Apex International Mfg., LLC on March 31, 2011 in Chaska, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chaska, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |