FDA Inspection 813393 — NGL NE LLP
The FDA completed an inspection of NGL NE LLP on Jan 9, 2013 in North Haven, 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 9, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |