SpecGx LLC
FDA inspection history in St. Louis, Missouri, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at St. Louis, Missouri.
Cited most
Across all SpecGx observations on file
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
- 21 CFR 314.81Other postmarketing reports1
The complete SpecGx file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
St. Louis, Missouri
One Form 483 · 2019 · 4 observations
Latest: Form 483, Sep 12, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-12 | 483 Form 483 | St. Louis, Missouri | 4 | $99 |
FEI number 1940521 · most recent document Sep 12, 2019
About SpecGx LLC
How many FDA Form 483s has SpecGx LLC received?
FDA Intel has 1 Form 483 on file for SpecGx LLC; the most recent is dated Sep 12, 2019.
When was SpecGx LLC last inspected by FDA?
The most recent FDA inspection document on file for SpecGx LLC is a Form 483 dated Sep 12, 2019, for the site in St. Louis, Missouri.
What did FDA cite at SpecGx LLC?
The regulations cited most in the observations on file for SpecGx LLC are 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 1 time.