Pharmascience Inc.
Form 483 issued February 13, 2024 · Candiac, Canada
- Inspection
- Feb 5 – Feb 13, 2024
- Investigator
- Jose M. Cayuela
- Observations
- 3
- Pages
- 5
- FEI number
- 3002806578
In short: On February 13, 2024, FDA issued a Form 483 with 3 observations to Pharmascience Inc. in Candiac, Quebec (FEI 3002806578) after an inspection that ran Feb 5 – Feb 13, 2024. The investigator was Jose M. Cayuela. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
The written stability testing program is not followed…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmPharmascience Inc. 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 Pharmascience Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmascience Inc.?
Jose M. Cayuela is named on this Form 483, for the inspection of Feb 5 – Feb 13, 2024. Each investigator has a profile showing what they cite most.
When was Pharmascience Inc. inspected by FDA?
The inspection ran Feb 5 – Feb 13, 2024, and the Form 483 is dated February 13, 2024.
How do I get the full Form 483 for Pharmascience 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.