ABS Corporation
Form 483 issued August 11, 2023 · Omaha, Nebraska
- Inspection
- Aug 8 – Aug 11, 2023
- Investigator
- Torrey M. Ward
- Observations
- 4
- Pages
- 4
- FEI number
- 1950042
In short: On August 11, 2023, FDA issued a Form 483 with 4 observations to ABS Corporation in Omaha, Nebraska (FEI 1950042) after an inspection that ran Aug 8 – Aug 11, 2023. The investigator was Torrey M. Ward. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Torrey M. Ward
13 documents · 2021–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Iowa.
The firmABS Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ABS Corporation?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected ABS Corporation?
Torrey M. Ward is named on this Form 483, for the inspection of Aug 8 – Aug 11, 2023. Each investigator has a profile showing what they cite most.
When was ABS Corporation inspected by FDA?
The inspection ran Aug 8 – Aug 11, 2023, and the Form 483 is dated August 11, 2023.
How do I get the full Form 483 for ABS Corporation?
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.