Bimeda-MTC Animal Health
Form 483 issued September 22, 2023 · Cambridge, Canada
- Inspection
- Sep 14 – Sep 22, 2023
- Investigators
- David A. Oluwo· Kenneth H. Williams
- Observations
- 2
- Pages
- 4
- FEI number
- 3001603179
In short: On September 22, 2023, FDA issued a Form 483 with 2 observations to Bimeda-MTC Animal Health in Cambridge, Ontario (FEI 3001603179) after an inspection that ran Sep 14 – Sep 22, 2023. The investigators were David A. Oluwo and Kenneth H. Williams. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
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 thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures describing the calibration of instruments, apparatus, and recording device are…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
The firmBimeda-MTC Animal Health history
The site's inspection history, in date order.
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 Bimeda-MTC Animal Health?
FDA listed 2 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 Bimeda-MTC Animal Health?
David A. Oluwo and Kenneth H. Williams are named on this Form 483, for the inspection of Sep 14 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Bimeda-MTC Animal Health inspected by FDA?
The inspection ran Sep 14 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Bimeda-MTC Animal Health?
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