FDA Inspection 584934 — CBI Laboratories, Inc.
The FDA completed an inspection of CBI Laboratories, Inc. on May 1, 2009 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 1, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 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. |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |
| 4576 | 21 CFR 211.192 | No written record of investigation |