FDA Inspection
Coupler LLCCoupler LLC – FDA Inspection, Aug 10, 2023
Record Details
This FDA Inspection record concerns Coupler LLC, with an inspection on August 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e58a2339-b50b-4582-b3e5-b6808f080aa8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1214374
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.122(g)(3)Visual inspection
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.122(g)(3)Visual inspection
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
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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 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 |
| May 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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