FDA Inspection
Medley Pharmaceuticals LimitedMedley Pharmaceuticals Limited – FDA Inspection, May 19, 2023
Record Details
This FDA Inspection record concerns Medley Pharmaceuticals Limited, with an inspection on May 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 38f497cb-2f3a-4131-b18a-d03dc1d9c5f0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1205651
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medley Pharmaceuticals Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2019 | VAI | Office of Inspections and Investigations | Generic Drug Evaluation |
| December 14, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Medley Pharmaceuticals Limited
- FDA Inspection 1098331 - 2019-07-31
- FDA Inspection 1154972 - 2018-12-14
- FDA Inspection 973541 - 2016-02-19
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.