FDA Inspection 1300468 — Safrel Pharmaceuticals LLC
The FDA completed an inspection of Safrel Pharmaceuticals LLC on January 30, 2026 in Dayton, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 30, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22907 | 21 CFR 111.475(b) | Records - written procedures holding and distribution; product distribution |
| 22911 | 21 CFR 111.535(b) | Make and keep records - returned dietary supplements |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |