FDA Inspection
Wedgewood Connect, LLCWedgewood Connect, LLC – FDA Inspection, Nov 17, 2023
Record Details
This FDA Inspection record concerns Wedgewood Connect, LLC, with an inspection on November 17, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a6ecabbd-0145-4b2c-b8cd-64b5e1e12373
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224880
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Untitled Letter
FDA Citations
15- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- Drug product labels, fails to include
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192No written record of investigation
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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 |
| 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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