FDA Inspection
Coupler LLCCoupler LLC – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns Coupler LLC, with an inspection on April 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 776a2060-dc6f-46ba-a84a-607ee2af918c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1049813
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Approval and review of procedures
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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 |
| March 10, 2020 | 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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