FDA Inspection 793901 — Hawknad Manufacturing Industries, Inc.
The FDA completed an inspection of Hawknad Manufacturing Industries, Inc. on August 15, 2012 in Alexandria, VA. 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
- August 15, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alexandria, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |