FDA Inspection 726123 — OPMX, LLC
The FDA completed an inspection of OPMX, LLC on May 31, 2011 in Chula Vista, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 31, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Chula Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |