FDA Inspection 1072711 — Nationwide Laboratories, LLC
The FDA completed an inspection of Nationwide Laboratories, LLC on November 27, 2018 in Iselin, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 27, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Iselin, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |