FDA Inspection 840313 — AMKS TIME RELEASE LAB, LLC
The FDA completed an inspection of AMKS TIME RELEASE LAB, LLC on July 12, 2013 in Paterson, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Paterson, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7482 | 21 CFR 312.50 | General responsibilities of sponsors |
| 7558 | 21 CFR 312.57(c) | Record retention requirement |
| 7631 | 21 CFR 312.53(c)(4) | Financial information - commitment to update |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |