BioVectra Inc.
Form 483 issued April 19, 2024 · Charlottetown, Canada
- Inspection
- Apr 15 – Apr 19, 2024
- Observations
- 2
- Pages
- 2
- FEI number
- 3004063541
In short: On April 19, 2024, FDA issued a Form 483 with 2 observations to BioVectra Inc. in Charlottetown, PE (FEI 3004063541) after an inspection that ran Apr 15 – Apr 19, 2024. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.180 (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
Written procedures are not followed for performing regular quality reviews of Active Pharmaceutical Ingredients (APIs) to…
- 02
Laboratory Controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
This inspection in context
Questions about this 483
What did FDA find at BioVectra Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
When was BioVectra Inc. inspected by FDA?
The inspection ran Apr 15 – Apr 19, 2024, and the Form 483 is dated April 19, 2024.
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.