FDA Inspection 820229 — OPMX, LLC
The FDA completed an inspection of OPMX, LLC on February 20, 2013 in Chula Vista, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 20, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Chula Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |