FDA Inspection 752959 — Caribe Natural LLC
The FDA completed an inspection of Caribe Natural LLC on November 23, 2011 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 23, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 15454 | 21 CFR 111.16 | Written procedures - pest control |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 15572 | 21 CFR 111.153 | Written procedures - labels |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16043 | 21 CFR 111.503 | Written procedures - returned dietary supplement; destroyed |
| 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 |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |