FDA Inspection 905859 — Coastal Meds, LLC
The FDA completed an inspection of Coastal Meds, LLC on November 10, 2014 in Biloxi, MS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 10, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Biloxi, MS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1416 | 21 CFR 211.42(c)(6) | Pkg / Labeling Operations Area |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |