SpecGx, LLC
Form 483 issued September 18, 2023 · Webster Groves, Missouri
- Inspection
- Sep 11 – Sep 18, 2023
- Investigator
- Monica E. Murie
- Observations
- 2
- Pages
- 3
- FEI number
- 3005275960
In short: On September 18, 2023, FDA issued a Form 483 with 2 observations to SpecGx, LLC in Webster Groves, Missouri (FEI 3005275960) after an inspection that ran Sep 11 – Sep 18, 2023. The investigator was Monica E. Murie. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SpecGx, LLC?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected SpecGx, LLC?
Monica E. Murie is named on this Form 483, for the inspection of Sep 11 – Sep 18, 2023. Each investigator has a profile showing what they cite most.
When was SpecGx, LLC inspected by FDA?
The inspection ran Sep 11 – Sep 18, 2023, and the Form 483 is dated September 18, 2023.
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.