FDA Inspection 1011479 — Syringa LLC
The FDA completed an inspection of Syringa LLC on March 16, 2017 in Idaho Falls, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |