SpecGx LLC
Form 483 issued September 12, 2019 · St. Louis, Missouri
- Observations
- 4
- Pages
- 4
- FEI number
- 1940521
In short: On September 12, 2019, FDA issued a Form 483 with 4 observations to SpecGx LLC in St. Louis, Missouri (FEI 1940521). Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 3 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Computerized systems should have sufficient controls to prevent unauthorized access or changes to data, There should…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Questions about this 483
What did FDA find at SpecGx LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was SpecGx LLC inspected by FDA?
This Form 483 is dated September 12, 2019.
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.