FDA Inspection 1161078 — Bi-Coastal Pharma International
The FDA completed an inspection of Bi-Coastal Pharma International on January 14, 2022 in Shrewsbury, NJ. 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
- January 14, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Shrewsbury, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |