Smithfield Bioscience, Inc.
Form 483 issued May 15, 2019 · Cincinnati, Ohio
- Inspection
- May 10 – May 15, 2019
- Observations
- 1
- Pages
- 3
- FEI number
- 1527761
In short: On May 15, 2019, FDA issued a Form 483 with 1 observation to Smithfield Bioscience, Inc. in Cincinnati, Ohio (FEI 1527761) after an inspection that ran May 10 – May 15, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to conduct…
This inspection in context
Questions about this 483
What did FDA find at Smithfield Bioscience, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Smithfield Bioscience, Inc. inspected by FDA?
The inspection ran May 10 – May 15, 2019, and the Form 483 is dated May 15, 2019.
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.