Smithfield Bioscience, Inc.
FDA inspection history in Cincinnati, Ohio, 2016 to 2025
- 4
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2019: one Form 483; 2022: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Cincinnati, Ohio.
- 2019One Form 483, at Cincinnati, Ohio.
- 2022One Form 483, at Cincinnati, Ohio.
- 2025One Form 483, at Cincinnati, Ohio.
- 2025The longest 483 on file: 6 observations over 6 pages at Cincinnati, Ohio.
Cited most
Across all Smithfield Bioscience observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.160General requirements3
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
The complete Smithfield Bioscience file.
All 4 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
Cincinnati, Ohio
Four Form 483s · 2016 to 2025 · 14 observations
Latest: Form 483, Dec 23, 2025 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-23 | 483 Form 483 | Cincinnati, Ohio | 6 | $99 |
| 2022-07-15 | 483 Form 483 | Cincinnati, Ohio | 3 | $99 |
| 2019-05-15 | 483 Form 483 | Cincinnati, Ohio | 1 | $99 |
| 2016-10-27 | 483 Form 483 | Cincinnati, Ohio | 4 | $99 |
Investigators on these documents
Amanda M. Dunneback (1)Anna M. Spiros (1)Lauren N. Howard (1)Lindsey M. Schwierjohann (1)Logan T. Williams (1)Martin M. Kimani (1)
FEI number 1527761 · most recent document Dec 23, 2025
About Smithfield Bioscience, Inc.
How many FDA Form 483s has Smithfield Bioscience, Inc. received?
FDA Intel has 4 Form 483s on file for Smithfield Bioscience, Inc.; the most recent is dated Dec 23, 2025.
When was Smithfield Bioscience, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Smithfield Bioscience, Inc. is a Form 483 dated Dec 23, 2025, for the site in Cincinnati, Ohio.
What did FDA cite at Smithfield Bioscience, Inc.?
The regulations cited most in the observations on file for Smithfield Bioscience, Inc. are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.194 (Laboratory records), 2 times.