FDA Inspection 719867 — Similasan Corporation
The FDA completed an inspection of Similasan Corporation on April 8, 2011 in Highlands Ranch, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Highlands Ranch, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 8935 | FDCA 760(b)(1) | Failure of responsible person to report AE (non-RX Drug) |