FDA Inspection
McNeil ABMcNeil AB – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns McNeil AB, with an inspection on May 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6bc07905-d30d-4a61-9433-aef205a544d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053240
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of McNeil AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 27, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for McNeil AB
- FDA Inspection 1268247 - 2022-06-15
- FDA Inspection 1124410 - 2019-11-27
- FDA Inspection 860131 - 2013-12-13
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