FDA Inspection 871333 — Sonar Products, Inc.
The FDA completed an inspection of Sonar Products, Inc. on March 18, 2014 in Carlstadt, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 18, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Carlstadt, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |