FDA Inspection
Medley Pharmaceuticals LimitedMedley Pharmaceuticals Limited – FDA Inspection, Jul 31, 2019
Record Details
This FDA Inspection record concerns Medley Pharmaceuticals Limited, with an inspection on July 31, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 0fb9d332-e223-48e4-b0fa-211413e829b2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098331
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Medley Pharmaceuticals Limited
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1205651 - 2023-05-19
- FDA Inspection 1154972 - 2018-12-14
- FDA Inspection 973541 - 2016-02-19
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