FDA Inspection 894091 — Goodier Cosmetics LLC
The FDA completed an inspection of Goodier Cosmetics LLC on September 5, 2014 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4375 | 21 CFR 211.188(b)(5) | In-process and laboratory control results |