FDA Inspection
SpecGx, LLCSpecGx, LLC – FDA Inspection, Jan 29, 2016
Record Details
This FDA Inspection record concerns SpecGx, LLC, with an inspection on January 29, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SpecGx, LLC
- Inspection Date
- January 29, 2016
- Product Type
- Drugs
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ID · 0a6da2e4-ebb4-4013-9e76-82e0a70decb3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 957282
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.188(a)Accurate reproduction included
- 21 CFR 211.142(b)Storage under appropriate conditions
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Other FDA inspections of SpecGx, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2025 | Not classified | New York District Office | Drug Quality Assurance |
| March 13, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 6, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SpecGx, LLC
- FDA Inspection 1256233 - 2025-01-17
- FDA Inspection 1122931 - 2020-03-13
- FDA Inspection 1049694 - 2018-04-06
- FDA Inspection 846761 - 2013-08-30
- FDA Inspection 777958 - 2012-04-20
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