FDA Inspection 584934 — CBI Laboratories, Inc. dba Voyant Beauty LLC.
The FDA completed an inspection of CBI Laboratories, Inc. dba Voyant Beauty LLC. on May 1, 2009 in Fort Worth, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (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 |