FDA Inspection 695488 — McNeil Healthcare, LLC
The FDA completed an inspection of McNeil Healthcare, LLC on November 2, 2010 in Las Piedras, PR. 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
- November 2, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Las Piedras, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |