Smithfield Bioscience, Inc.
Form 483 issued July 15, 2022 · Cincinnati, Ohio
- Inspection
- Jul 11 – Jul 15, 2022
- Investigators
- Amanda M. Dunneback· Lauren N. Howard
- Observations
- 3
- Pages
- 4
- FEI number
- 1527761
In short: On July 15, 2022, FDA issued a Form 483 with 3 observations to Smithfield Bioscience, Inc. in Cincinnati, Ohio (FEI 1527761) after an inspection that ran Jul 11 – Jul 15, 2022. The investigators were Amanda M. Dunneback and Lauren N. Howard. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
***REPEAT OBSERVATION FROM FDA 2019 INSPECTION*** Failure to conduct thorough investigations into unexplained discrepancies and the…
- 02
Environmental monitoring is not representative…
- 03
Contract testing laboratories are not fully qualified to ensure compliance with GMPs prior to…
This inspection in context
Amanda M. Dunneback
1 document · 2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Ohio.
The firmSmithfield Bioscience, Inc. history
All 4 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 Smithfield Bioscience, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Smithfield Bioscience, Inc.?
Amanda M. Dunneback and Lauren N. Howard are named on this Form 483, for the inspection of Jul 11 – Jul 15, 2022. Each investigator has a profile showing what they cite most.
When was Smithfield Bioscience, Inc. inspected by FDA?
The inspection ran Jul 11 – Jul 15, 2022, and the Form 483 is dated July 15, 2022.
How do I get the full Form 483 for Smithfield Bioscience, 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.