FDA Inspection 988951 — Nationwide Laboratories, LLC
The FDA completed an inspection of Nationwide Laboratories, LLC on August 19, 2016 in Iselin, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Iselin, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |