FDA Inspection 1163035 — Mohnark Pharmaceuticals Inc
The FDA completed an inspection of Mohnark Pharmaceuticals Inc on February 25, 2022 in Fort Pierce, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 25, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Pierce, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4395 | 21 CFR 211.186(b)(4) | Weight or measure of each component |