FDA Inspection
Coupler LLCCoupler LLC – FDA Inspection, Mar 10, 2020
Record Details
This FDA Inspection record concerns Coupler LLC, with an inspection on March 10, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coupler LLC
- Inspection Date
- March 10, 2020
- Product Type
- Drugs
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ID · 4eaeebeb-2aab-4c7a-b579-5eeb3bee1eb2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1120463
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Coupler LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| August 10, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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