Smithfield Bioscience, Inc.
Form 483 issued October 27, 2016 · Cincinnati, Ohio
- Investigator
- Lindsey M. Schwierjohann
- Observations
- 4
- Pages
- 3
- FEI number
- 1527761
In short: On October 27, 2016, FDA issued a Form 483 with 4 observations to Smithfield Bioscience, Inc. in Cincinnati, Ohio (FEI 1527761). The investigator was Lindsey M. Schwierjohann. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to validate laboratory…
- 02
Oversight over the electronic systems and data in…
- 03
The testing procedure for…
- 04
Document control of production batch records by the…
This inspection in context
Lindsey M. Schwierjohann
6 documents · 2015–2019
Cites 211.188 (batch production and control records) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Smithfield Bioscience, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Smithfield Bioscience, Inc.?
Lindsey M. Schwierjohann is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Smithfield Bioscience, Inc. inspected by FDA?
This Form 483 is dated October 27, 2016.
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.