FDA Inspection
SpecGx, LLCSpecGx, LLC – FDA Inspection, Aug 30, 2013
Record Details
This FDA Inspection record concerns SpecGx, LLC, with an inspection on August 30, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SpecGx, LLC
- Inspection Date
- August 30, 2013
- Product Type
- Drugs
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ID · c4acd70f-150c-4eb9-94be-c1c8799ea817
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 846761
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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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 |
| January 29, 2016 | 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 957282 - 2016-01-29
- FDA Inspection 777958 - 2012-04-20
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