FDA Inspection
A.P. Deauville, LLCA.P. Deauville, LLC – FDA Inspection, Aug 25, 2022
Record Details
This FDA Inspection record concerns A.P. Deauville, LLC, with an inspection on August 25, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- A.P. Deauville, LLC
- Inspection Date
- August 25, 2022
- Product Type
- Drugs
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ID · 2feeaf22-f2d7-4bcb-995d-8799bdbed910
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1178179
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Absence of Written Procedures
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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 |
| 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 |
| 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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