FDA Inspection 862837 — CBI Laboratories, Inc.
The FDA completed an inspection of CBI Laboratories, Inc. on Feb 14, 2014 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Worth, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |