FDA Inspection 1010916 — Leading Pharma, LLC
The FDA completed an inspection of Leading Pharma, LLC on Apr 14, 2017 in Fairfield, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fairfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |