FDA Inspection
Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited – FDA Inspection, Jan 25, 2019
Record Details
This FDA Inspection record concerns Macleods Pharmaceuticals Limited, with an inspection on January 25, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 12183bc2-ee2d-4877-890e-cb9037dac461
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077302
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Macleods Pharmaceuticals Limited
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1206441 - 2023-05-26
- FDA Inspection 1014132 - 2017-05-29
- FDA Inspection 859008 - 2013-11-15
- FDA Inspection 717278 - 2011-02-24
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