FDA Inspection
Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited – FDA Inspection, Oct 20, 2023
Record Details
This FDA Inspection record concerns Macleods Pharmaceuticals Limited, with an inspection on October 20, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a5d0a744-e951-4a78-b39b-ba819c52b02a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1220834
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.110(b)In-process materials specifications
- 21 CFR 211.113(a)Procedures for non-sterile drug products
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Other FDA inspections of Macleods Pharmaceuticals Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 24, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 10, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Macleods Pharmaceuticals Limited
- FDA Inspection 1157334 - 2021-11-01
- FDA Inspection 1032020 - 2017-11-24
- FDA Inspection 926324 - 2015-05-15
- FDA Inspection 833839 - 2013-02-22
- FDA Inspection 701340 - 2010-12-10
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