FDA Inspection
FNC Medical CorporationFNC Medical Corporation – FDA Inspection, Sep 11, 2026
Record Details
This FDA Inspection record concerns FNC Medical Corporation, with an inspection on September 11, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · 4a4c69a3-4746-490d-930e-e43edbcfb334
Inspection Facts
- Inspection number
- 1335294
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.80(d)Identification of Each Lot in Each Shipment
- 21 CFR 211.84(d)(1)Component identity verification
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Other FDA inspections of FNC Medical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 21, 2011 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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