FDA Inspection
Sigan America LlcSigan America Llc – FDA Inspection, Sep 29, 2026
Record Details
This FDA Inspection record concerns Sigan America Llc, with an inspection on September 29, 2026, issued by the Chicago District Office, covering human drugs.
- Office
- Chicago District Office
- People
- Angela C. Welker (Issuing Officer)
- Chikitsa S. Patel (Issuing Officer)
- JeanClaude Garay (Issuing Officer)
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ID · 859c9eab-5421-4044-8079-cd4ff12f3d25
Inspection Facts
- Inspection number
- 1302424
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
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Other FDA inspections of Sigan America Llc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2013 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for Sigan America Llc
- FDA Inspection 1180818 - 2022-09-01
- FDA Inspection 822263 - 2013-03-13
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