FDA Inspection 1296658 — International Medication Systems Ltd.
The FDA completed an inspection of International Medication Systems Ltd. on December 19, 2025 in South El Monte, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- South El Monte, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 22943 | FDCA 582(b)(2)(A) | Product identifier - record keeping |
| 3554 | 21 CFR 211.48(a) | Potable water standards not met |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |