FDA Inspection 780318 — DermaRite Industries, LLC
The FDA completed an inspection of DermaRite Industries, LLC on May 10, 2012 in North Bergen, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Bergen, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |