FDA Inspection 839653 — Hawknad Manufacturing Industries, Inc.
The FDA completed an inspection of Hawknad Manufacturing Industries, Inc. on August 2, 2013 in Alexandria, VA. 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
- August 2, 2013
- Fiscal Year
- 2013
- 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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |