FDA Inspection
Coupler LLCCoupler LLC – FDA Inspection, Mar 2, 2026
Record Details
This FDA Inspection record concerns Coupler LLC, with an inspection on March 2, 2026, issued by the Philadelphia District Office, covering human drugs.
- Person
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ID · a3ad6c81-de4f-4f5e-a78e-1fd60e9dfae0
Inspection Facts
- Inspection number
- 1308780
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.94(b)Protection from external factors
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Other FDA inspections of Coupler LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| May 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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