FDA Inspection 1000207 — Centrix, Inc.
The FDA completed an inspection of Centrix, Inc. on Jan 31, 2017 in Shelton, 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Shelton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |