FDA Inspection
Similasan CorporationSimilasan Corporation – FDA Inspection, Apr 8, 2011
Record Details
This FDA Inspection record concerns Similasan Corporation, with an inspection on April 8, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Similasan Corporation
- Inspection Date
- April 8, 2011
- Product Type
- Drugs
View Company Profile
ID · 6ac8e157-8ed3-4518-b8af-be06f63cd513
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 719867
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.198(b)(3)Reason for Not Conducting Complaint Investigation
- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.142Written warehousing procedures established/followed
- Failure of responsible person to report AE (non-RX Drug)
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Similasan Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2013 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Similasan Corporation
- FDA Inspection 856058 - 2013-11-20
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