FDA Inspection 920704 — Whitney Labs LP
The FDA completed an inspection of Whitney Labs LP on March 31, 2015 in Ormond Beach, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Ormond Beach, 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 |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 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 |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2044 | 21 CFR 211.196 | Distribution Record Requirements |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |