Sterinova Inc.
Form 483 issued September 7, 2022 · Saint-Hyacinthe, Canada
- Inspection
- Aug 29 – Sep 7, 2022
- Investigator
- Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 3
- FEI number
- 3011699563
In short: On September 7, 2022, FDA issued a Form 483 with 2 observations to Sterinova Inc. in Saint-Hyacinthe, Quebec (FEI 3011699563) after an inspection that ran Aug 29 – Sep 7, 2022. The investigator was Jonathan G. Matrisciano. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSterinova Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sterinova Inc.?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sterinova Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Aug 29 – Sep 7, 2022. Each investigator has a profile showing what they cite most.
When was Sterinova Inc. inspected by FDA?
The inspection ran Aug 29 – Sep 7, 2022, and the Form 483 is dated September 7, 2022.
How do I get the full Form 483 for Sterinova 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.