FDA Inspection 1068177 — Red Mountain Inc
The FDA completed an inspection of Red Mountain Inc on Oct 11, 2018 in Oakland Park, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 11, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oakland Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |