FDA Inspection
Wedgewood Connect, LLCWedgewood Connect, LLC – FDA Inspection, Jul 3, 2025
Record Details
This FDA Inspection record concerns Wedgewood Connect, LLC, with an inspection on July 3, 2025, issued by the San Francisco District Office, covering human drugs.
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ID · 115ec082-9499-402b-8e29-21e7b32263e2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1275280
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.166(a)(4)Testing in same container - closure system
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Wedgewood Connect, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 7, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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