FDA Inspection 667709 — Sonar Products, Inc.
The FDA completed an inspection of Sonar Products, Inc. on June 21, 2010 in Carlstadt, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 21, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carlstadt, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |