FDA Inspection
Wedgewood Connect, LLCWedgewood Connect, LLC – FDA Inspection, Dec 3, 2021
Record Details
This FDA Inspection record concerns Wedgewood Connect, LLC, with an inspection on December 3, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wedgewood Connect, LLC
- Inspection Date
- December 3, 2021
- Product Type
- Drugs
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ID · 4e0c845d-396d-4b3b-91a2-a4d4b56e960c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1158151
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 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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