FDA Inspection 1092576 — Cross Brands Contract Filling, LLC
The FDA completed an inspection of Cross Brands Contract Filling, LLC on June 10, 2019 in West Melbourne, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |