FDA Inspection
Wedgewood Connect, LLCWedgewood Connect, LLC – FDA Inspection, Mar 6, 2014
Record Details
This FDA Inspection record concerns Wedgewood Connect, LLC, with an inspection on March 6, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wedgewood Connect, LLC
- Inspection Date
- March 6, 2014
- Product Type
- Drugs
View Company Profile
ID · 325e7a33-ef76-49dc-a78a-4d946ce86156
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 870667
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
9- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| June 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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