FDA Inspection 895290 — International Medication Systems Ltd.
The FDA completed an inspection of International Medication Systems Ltd. on Sep 12, 2014 in South El Monte, CA. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South El Monte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |