FDA Inspection
SpecGx, LLCSpecGx, LLC – FDA Inspection, Apr 20, 2012
Record Details
This FDA Inspection record concerns SpecGx, LLC, with an inspection on April 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SpecGx, LLC
- Inspection Date
- April 20, 2012
- Product Type
- Drugs
View Company Profile
ID · 48a8b9e0-b177-4cf7-985f-74dc17db966d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777958
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.111Establishment of time limitations
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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 |
| August 30, 2013 | 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 846761 - 2013-08-30
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