FDA Inspection 1234985 — Opti Source International
The FDA completed an inspection of Opti Source International on Apr 4, 2024 in Bellport, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 4, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bellport, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |