FDA Inspection 1250450 — DermaRite Industries, LLC
The FDA completed an inspection of DermaRite Industries, LLC on April 8, 2025 in North Bergen, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Bergen, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |