FDA Inspection 652016 — J & L Medical Services, LLC
The FDA completed an inspection of J & L Medical Services, LLC on Mar 17, 2010 in Middlebury, CT. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Middlebury, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |