FDA Inspection 1009141 — Medsource Pharmaceuticals
The FDA completed an inspection of Medsource Pharmaceuticals on February 10, 2017 in Rancho Santa Margarita, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 10, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rancho Santa Margarita, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |