FDA Inspection
FNC Medical CorporationFNC Medical Corporation – FDA Inspection, Nov 8, 2012
Record Details
This FDA Inspection record concerns FNC Medical Corporation, with an inspection on November 8, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- FNC Medical Corporation
- Inspection Date
- November 8, 2012
- Product Type
- Drugs
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ID · b5459fed-8008-4fda-9d5d-85933259a988
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817179
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(b)Representative Samples Criteria
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of FNC Medical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | Not classified | Los Angeles District Office | Drug Quality Assurance |
| 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 |
| July 21, 2011 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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