FDA Inspection
Cantrell Drug CompanyCantrell Drug Company – FDA Inspection, Jun 29, 2017
Record Details
This FDA Inspection record concerns Cantrell Drug Company, with an inspection on June 29, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 06011c55-f67f-41d7-b119-f822a53562a1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1016395
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.113(b)Procedures for sterile drug products
- FDCA 503B(a)(10)Drug product label, outsourcer facility
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Cantrell Drug Company
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 22, 2018 | 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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