FDA Inspection
Sigan Industries Group Inc.Sigan Industries Group Inc. – FDA Inspection, May 23, 2025
Record Details
This FDA Inspection record concerns Sigan Industries Group Inc., with an inspection on May 23, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · eec96987-fc07-466c-aabc-386af40d2705
Inspection Facts
- Inspection number
- 1264005
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Sigan Industries Group Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sigan Industries Group Inc.
- FDA Inspection 1105499 - 2019-08-22
- FDA Inspection 994051 - 2016-11-18
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