BioVectra Inc.
Form 483 issued August 26, 2022 · Charlottetown, Canada
- Inspection
- Aug 22 – Aug 26, 2022
- Investigator
- Jonathan G. Matrisciano
- Observations
- 2
- Pages
- 2
- FEI number
- 3004063541
In short: On August 26, 2022, FDA issued a Form 483 with 2 observations to BioVectra Inc. in Charlottetown, PE (FEI 3004063541) after an inspection that ran Aug 22 – Aug 26, 2022. The investigator was Jonathan G. Matrisciano. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.180 (1×)
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 non-sterile Active Pharmaceutical Ingredients…
- 02
Written procedures are not followed for performing regular quality reviews of all Active Pharmaceutical Ingredients to…
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 firmBioVectra Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 BioVectra Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected BioVectra Inc.?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Aug 22 – Aug 26, 2022. Each investigator has a profile showing what they cite most.
When was BioVectra Inc. inspected by FDA?
The inspection ran Aug 22 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.
How do I get the full Form 483 for BioVectra 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.