FDA Inspection
Wedgewood Connect, LLCWedgewood Connect, LLC – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Wedgewood Connect, LLC, with an inspection on June 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d50cb32e-6ae1-4526-9efc-906bb8ae9822
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014307
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Wedgewood Connect, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 3, 2025 | VAI | San Francisco District Office | Drug Quality Assurance |
| 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 |
| October 7, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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