FDA Inspection 1014690 — InvaDerm, Inc.
The FDA completed an inspection of InvaDerm, Inc. on June 15, 2017 in Somerset, NJ. 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
- June 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |