FDA Inspection
SpecGx, LLCSpecGx, LLC – FDA Inspection, Jan 17, 2025
Record Details
This FDA Inspection record concerns SpecGx, LLC, with an inspection on January 17, 2025, issued by the New York District Office, covering human drugs.
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ID · cd344519-970f-4651-bec9-c3780e297826
Inspection Facts
- Inspection number
- 1256233
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of SpecGx, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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 1122931 - 2020-03-13
- FDA Inspection 1049694 - 2018-04-06
- FDA Inspection 957282 - 2016-01-29
- FDA Inspection 846761 - 2013-08-30
- FDA Inspection 777958 - 2012-04-20
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