FDA Inspection
Coupler LLCCoupler LLC – FDA Inspection, May 29, 2013
Record Details
This FDA Inspection record concerns Coupler LLC, with an inspection on May 29, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Coupler LLC
- Inspection Date
- May 29, 2013
- Product Type
- Drugs
View Company Profile
ID · b038bab9-8004-4c08-94af-c4293266fb24
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833469
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.100(a)Approval and review of procedures
- 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 |
| March 10, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 27, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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