FDA Inspection
A.P. Deauville, LLCA.P. Deauville, LLC – FDA Inspection, Feb 1, 2016
Record Details
This FDA Inspection record concerns A.P. Deauville, LLC, with an inspection on February 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- A.P. Deauville, LLC
- Inspection Date
- February 1, 2016
- Product Type
- Drugs
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ID · f946ae7d-ebb0-417c-b0a7-9ec3fb69f49b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964161
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.101(c)Weighing/measuring/subdividing supervision
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
Showing 10 of 13 citations.
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Other FDA inspections of A.P. Deauville, LLC
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|---|---|---|---|
| January 23, 2025 | OAI | Philadelphia District Office | Drug Quality Assurance |
| August 25, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 2, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2017 | 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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