FDA Inspection 704290 — Novartis Pharmaceuticals Corp.
The FDA completed an inspection of Novartis Pharmaceuticals Corp. on Dec 21, 2010 in Suffern, NY. 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
- Dec 21, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suffern, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4374 | 21 CFR 211.188(b)(6) | Inspection of packaging and labeling area |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |