FDA Inspection
Medefil IncorporatedMedefil Incorporated – FDA Inspection, May 25, 2012
Record Details
This FDA Inspection record concerns Medefil Incorporated, with an inspection on May 25, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medefil Incorporated
- Inspection Date
- May 25, 2012
- Product Type
- Drugs
View Company Profile
ID · 94ac6ce1-ce30-4809-a79f-99613f4a7991
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781769
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medefil Incorporated
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2025 | Not classified | Chicago District Office | |
| February 2, 2024 | Not classified | Chicago District Office | Drug Quality Assurance |
| March 29, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| June 17, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 15, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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