FDA Inspection
Medefil IncorporatedMedefil Incorporated – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Medefil Incorporated, with an inspection on March 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e62338a1-42a7-4a41-a48e-12108a4fc367
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046065
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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 |
| 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 |
| December 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medefil Incorporated
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.