ARG Laboratories, Inc
Form 483 issued September 20, 2023 · Dallas, Texas
- Inspection
- Sep 11 – Sep 20, 2023
- Investigators
- Michelle A. Krayer· Shelby N. Turner
- Observations
- 7
- Pages
- 11
- FEI number
- 3002556034
In short: On September 20, 2023, FDA issued a Form 483 with 7 observations to ARG Laboratories, Inc in Dallas, Texas (FEI 3002556034) after an inspection that ran Sep 11 – Sep 20, 2023. The investigators were Michelle A. Krayer and Shelby N. Turner. Most observations concern laboratory controls and materials.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 03
Dmg products failing to meet established standards, specifications and quality control…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
This inspection in context
Michelle A. Krayer
11 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmARG Laboratories, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ARG Laboratories, Inc?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, materials and quality system. The opening words of each observation are shown on this page.
Who inspected ARG Laboratories, Inc?
Michelle A. Krayer and Shelby N. Turner are named on this Form 483, for the inspection of Sep 11 – Sep 20, 2023. Each investigator has a profile showing what they cite most.
When was ARG Laboratories, Inc inspected by FDA?
The inspection ran Sep 11 – Sep 20, 2023, and the Form 483 is dated September 20, 2023.
How do I get the full Form 483 for ARG Laboratories, Inc?
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.