FDA Inspection 1178224 — Knoa Pharmaceuticals LLC
The FDA completed an inspection of Knoa Pharmaceuticals LLC on August 11, 2022 in Wilson, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wilson, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4354 | 21 CFR 211.165(d) | Acceptance/Rejection Levels |
| 4381 | 21 CFR 211.198(b)(2) | Written investigation record or copy kept at establishment |