FDA Inspection
Medefil IncorporatedMedefil Incorporated – FDA Inspection, Feb 19, 2009
Record Details
This FDA Inspection record concerns Medefil Incorporated, with an inspection on February 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medefil Incorporated
- Inspection Date
- February 19, 2009
- Product Type
- Devices
View Company Profile
ID · ba9c0936-ae2a-4bed-b437-dcc524591983
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 562313
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.100(a)(2)Investigation procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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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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