FDA Inspection 762655 — Whitney Labs LP
The FDA completed an inspection of Whitney Labs LP on January 26, 2012 in Ormond Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ormond Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |