FDA Inspection 806119 — Dermazone LLC
The FDA completed an inspection of Dermazone LLC on November 1, 2012 in Saint Petersburg, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2196 | 21 CFR 211.186(b)(1) | Product Name and Strength |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |