FDA Inspection 732884 — A.I.G Technologies Inc.
The FDA completed an inspection of A.I.G Technologies Inc. on Jul 1, 2011 in Deerfield Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Deerfield Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1163 | 21 CFR 211.28(b) | Habits of good sanitation & health |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |