FDA Inspection
A.P. Deauville, LLCA.P. Deauville, LLC – FDA Inspection, May 2, 2019
Record Details
This FDA Inspection record concerns A.P. Deauville, LLC, with an inspection on May 2, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b03d7152-cb8d-4c67-a593-3719616b4093
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1088861
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
14- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of A.P. Deauville, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | OAI | Philadelphia District Office | Drug Quality Assurance |
| August 25, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2013 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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