FDA Inspection
A.P. Deauville, LLCA.P. Deauville, LLC – FDA Inspection, Sep 19, 2017
Record Details
This FDA Inspection record concerns A.P. Deauville, LLC, with an inspection on September 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2cde1c72-0c53-4b27-95e3-353d04505c56
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025686
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 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 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| February 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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