FDA Inspection 1030174 — DermaRite Industries, LLC
The FDA completed an inspection of DermaRite Industries, LLC on Oct 30, 2017 in North Bergen, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Bergen, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |