FDA Inspection 636070 — Chemolee Lab Corporation
The FDA completed an inspection of Chemolee Lab Corporation on December 21, 2009 in Irving, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 17 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |