FDA Inspection 844933 — Syntho Pharmaceuticals, Inc.
The FDA completed an inspection of Syntho Pharmaceuticals, Inc. on August 23, 2013 in Farmingdale, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |