FDA Inspection
Cantrell Drug CompanyCantrell Drug Company – FDA Inspection, Aug 22, 2018
Record Details
This FDA Inspection record concerns Cantrell Drug Company, with an inspection on August 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 77c922da-1317-42b2-bfd2-26f7166ab025
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1062937
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.46(b)Equipment for Environmental Control
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Other FDA inspections of Cantrell Drug Company
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 14, 2016 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 4, 2013 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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