FDA Inspection
Cantrell Drug CompanyCantrell Drug Company – FDA Inspection, Oct 14, 2016
Record Details
This FDA Inspection record concerns Cantrell Drug Company, with an inspection on October 14, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Latorie S. Jones (FDA Associated Person)
- Lisa R. Whitt (Issuing Officer)
- Shelby N. Turner (Investigator)
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ID · 3d64491a-b19e-448f-a213-459743733749
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 990072
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- FDCA 503B(a)(10)Drug product label, outsourcer facility
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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 |
| June 29, 2017 | 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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