FDA Inspection
SpecGx LLCSpecGx LLC – FDA Inspection, Nov 22, 2016
Record Details
This FDA Inspection record concerns SpecGx LLC, with an inspection on November 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 6828282d-6ad1-439a-b2b4-d13d284884a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994662
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of SpecGx LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2025 | Not classified | Kansas City District Office | |
| February 11, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 12, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 24, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SpecGx LLC
- FDA Inspection 1283454 - 2025-10-22
- FDA Inspection 1163660 - 2022-02-11
- FDA Inspection 1103208 - 2019-09-12
- FDA Inspection 883175 - 2014-06-12
- FDA Inspection 834018 - 2013-05-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.