FDA Inspection 980679 — Hawknad Manufacturing Industries, Inc.
The FDA completed an inspection of Hawknad Manufacturing Industries, Inc. on April 28, 2016 in Alexandria, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 28, 2016
- Fiscal Year
- 2016
- 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 |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4576 | 21 CFR 211.192 | No written record of investigation |