Owens & Minor, Inc. dba American Contract Systems, Inc.
Form 483 issued August 14, 2024 · Ohio
- Inspection
- Aug 5 – Aug 14, 2024
- Investigators
- Dennis R. Hock· Katelyn A. Staub-Zamperini· Rosanna M. Goodrich
- Observations
- 4
- Pages
- 5
- FEI number
- 3008492337
In short: On August 14, 2024, FDA issued a Form 483 with 4 observations to Owens & Minor, Inc. dba American Contract Systems, Inc. in Ohio (FEI 3008492337) after an inspection that ran Aug 5 – Aug 14, 2024. The investigators were Dennis R. Hock, Katelyn A. Staub-Zamperini and Rosanna M. Goodrich. Most observations concern production & process controls and management controls.
At a glance
Production & process controls and management controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance of incoming product have…
- 0221 CFR 820.20(b)21 CFR 820
The organizational structure has not been adequately established and maintained to ensure that devices are designed…
- 03
The design history file was not established and does not demonstrate that the design was developed…
- 04
Process validation activities and results have…
This inspection in context
Dennis R. Hock
10 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmOwens & Minor, Inc. dba American Contract Systems, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Owens & Minor, Inc. dba American Contract Systems, Inc.?
FDA listed 4 observations on this Form 483, mostly about production & process controls, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Owens & Minor, Inc. dba American Contract Systems, Inc.?
Dennis R. Hock, Katelyn A. Staub-Zamperini and Rosanna M. Goodrich are named on this Form 483, for the inspection of Aug 5 – Aug 14, 2024. Each investigator has a profile showing what they cite most.
When was Owens & Minor, Inc. dba American Contract Systems, Inc. inspected by FDA?
The inspection ran Aug 5 – Aug 14, 2024, and the Form 483 is dated August 14, 2024.
How do I get the full Form 483 for Owens & Minor, Inc. dba American Contract Systems, 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.