Owens & Minor, Inc. dba American Contract Systems, Inc.
FDA inspection history across 3 sites, 2011 to 2024
- 2
- Warning letters
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2011: one warning letter; 2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter, at Bloomington, Minnesota.
- 2024One warning letter and one Form 483, at Mechanicsville, Virginia and Ohio.
Cited most
Across all Owens & Minor, Inc. dba American Contract Systems observations on file
- 21 CFR 8201
- 21 CFR 820.20(b)Management responsibility1
- 21 CFR 820.30(j)Design controls1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.80(b)Receiving, in-process, and finished device acceptance1
The complete Owens & Minor, Inc. dba American Contract Systems file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Mechanicsville, Virginia
One warning letter · 2024
Latest: Warning letter, Nov 1, 2024 →Ohio
One Form 483 · 2024 · 4 observations
Latest: Form 483, Aug 14, 2024 →Bloomington, Minnesota
One warning letter · 2011
Latest: Warning letter, Apr 21, 2011 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-01 | Warning letter Warning letter | Mechanicsville, Virginia | — | $99 |
| 2024-08-14 | 483 Form 483 | Ohio | 4 | $99 |
| 2011-04-21 | Warning letter Warning letter | Bloomington, Minnesota | — | $99 |
Investigators on these documents
Dennis R. Hock (1)Katelyn A. Staub-Zamperini (1)Rosanna M. Goodrich (1)
FEI number 3008492337 · most recent document Nov 1, 2024
About Owens & Minor, Inc. dba American Contract Systems, Inc.
How many FDA Form 483s has Owens & Minor, Inc. dba American Contract Systems, Inc. received?
FDA Intel has 1 Form 483 on file for Owens & Minor, Inc. dba American Contract Systems, Inc.; the most recent is dated Aug 14, 2024.
When was Owens & Minor, Inc. dba American Contract Systems, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Owens & Minor, Inc. dba American Contract Systems, Inc. is a Form 483 dated Aug 14, 2024, for the site in Ohio.
What did FDA cite at Owens & Minor, Inc. dba American Contract Systems, Inc.?
The regulations cited most in the observations on file for Owens & Minor, Inc. dba American Contract Systems, Inc. are 21 CFR 820, 1 time; 21 CFR 820.20(b) (Management responsibility), 1 time; 21 CFR 820.30(j) (Design controls), 1 time.
Has Owens & Minor, Inc. dba American Contract Systems, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Owens & Minor, Inc. dba American Contract Systems, Inc.; the most recent is dated Nov 1, 2024.