SpecGx, LLC
FDA inspection history in Webster Groves, Missouri, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at Webster Groves, Missouri.
- 2021The longest 483 on file: 6 observations over 8 pages at Webster Groves, Missouri.
Cited most
Across all SpecGx observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.56Sanitation1
The complete SpecGx file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Webster Groves, Missouri
Two Form 483s · 2021 to 2023 · 8 observations
Latest: Form 483, Sep 18, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-18 | 483 Form 483 | Webster Groves, Missouri | 2 | $99 |
| 2021-09-17 | 483 Form 483 | Webster Groves, Missouri | 6 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Joseph A. Piechocki (1)Monica E. Murie (1)
FEI number 3005275960 · most recent document Sep 18, 2023
About SpecGx, LLC
How many FDA Form 483s has SpecGx, LLC received?
FDA Intel has 2 Form 483s on file for SpecGx, LLC; the most recent is dated Sep 18, 2023.
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 18, 2023, for the site in Webster Groves, Missouri.
What did FDA cite at SpecGx, LLC?
The regulations cited most in the observations on file for SpecGx, LLC are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.