SpecGx, LLC
Form 483 issued September 17, 2021 · Webster Groves, Missouri
- Inspection
- Sep 13 – Sep 17, 2021
- Investigators
- Arsen Karapetyan· Joseph A. Piechocki
- Observations
- 6
- Pages
- 8
- FEI number
- 3005275960
In short: On September 17, 2021, FDA issued a Form 483 with 6 observations to SpecGx, LLC in Webster Groves, Missouri (FEI 3005275960) after an inspection that ran Sep 13 – Sep 17, 2021. The investigators were Arsen Karapetyan and Joseph A. Piechocki. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The control systems necessary to prevent contamination…
- 02
Each component is not tested for conformity with all appropriate written specifications for…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmSpecGx, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SpecGx, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected SpecGx, LLC?
Arsen Karapetyan and Joseph A. Piechocki are named on this Form 483, for the inspection of Sep 13 – Sep 17, 2021. Each investigator has a profile showing what they cite most.
When was SpecGx, LLC inspected by FDA?
The inspection ran Sep 13 – Sep 17, 2021, and the Form 483 is dated September 17, 2021.
How do I get the full Form 483 for SpecGx, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.