FDA Inspection
Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited – FDA Inspection, May 26, 2023
Record Details
This FDA Inspection record concerns Macleods Pharmaceuticals Limited, with an inspection on May 26, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4d34d441-5fb3-4828-ac69-0bbdaee59242
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206441
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.63Equipment Design, Size and Location
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Other FDA inspections of Macleods Pharmaceuticals Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2019 | VAI | Office of Inspections and Investigations | New Drug Evaluation |
| May 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Macleods Pharmaceuticals Limited
- FDA Inspection 1077302 - 2019-01-25
- FDA Inspection 1014132 - 2017-05-29
- FDA Inspection 859008 - 2013-11-15
- FDA Inspection 717278 - 2011-02-24
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