Laboratoire du-Var Inc
Form 483 issued October 20, 2023 · Boucherville, Canada
- Inspection
- Oct 16 – Oct 20, 2023
- Investigator
- Jessica S. Estriplet
- Observations
- 4
- Pages
- 4
- FEI number
- 3002449500
In short: On October 20, 2023, FDA issued a Form 483 with 4 observations to Laboratoire du-Var Inc in Boucherville, Quebec (FEI 3002449500) after an inspection that ran Oct 16 – Oct 20, 2023. The investigator was Jessica S. Estriplet. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of the methods…
- 03
The quality control unit lacks the responsibility and authority to approve and reject all…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jessica S. Estriplet
18 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmLaboratoire du-Var Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratoire du-Var Inc?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Laboratoire du-Var Inc?
Jessica S. Estriplet is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2023. Each investigator has a profile showing what they cite most.
When was Laboratoire du-Var Inc inspected by FDA?
The inspection ran Oct 16 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.
How do I get the full Form 483 for Laboratoire du-Var Inc?
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