FDA Inspection 606511 — AV Industries, Inc.
The FDA completed an inspection of AV Industries, Inc. on August 13, 2009 in Caguas, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 13, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3636 | 21 CFR 211.170(b)(3) | Retention time for some OTC drugs |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |