Smithfield Bioscience, Inc.
Form 483 issued December 23, 2025 · Cincinnati, Ohio
- Inspection
- Dec 16 – Dec 23, 2025
- Investigators
- Anna M. Spiros· Logan T. Williams· Martin M. Kimani
- Observations
- 6
- Pages
- 6
- FEI number
- 1527761
In short: On December 23, 2025, FDA issued a Form 483 with 6 observations to Smithfield Bioscience, Inc. in Cincinnati, Ohio (FEI 1527761) after an inspection that ran Dec 16 – Dec 23, 2025. The investigators were Anna M. Spiros, Logan T. Williams and Martin M. Kimani. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process Validation performed does not demonstrate that critical process parameters produce consistent APIs meeting…
- 02
Supplier qualification do not include evaluations that provide adequate evidence that the manufacturer can consistently…
- 03
Batch records and laboratory records of critical steps are not reviewed and approved by…
- 04
***REPEAT OBSERVATION FROM FDA 2019 INSPECTION*** Failure to conduct thorough investigations into unexplained discrepancies and the…
This inspection in context
Anna M. Spiros
6 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
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 6 observations on this Form 483, mostly about quality system, production and materials. 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.?
Anna M. Spiros, Logan T. Williams and Martin M. Kimani are named on this Form 483, for the inspection of Dec 16 – Dec 23, 2025. Each investigator has a profile showing what they cite most.
When was Smithfield Bioscience, Inc. inspected by FDA?
The inspection ran Dec 16 – Dec 23, 2025, and the Form 483 is dated December 23, 2025.
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.