Dermolab Pharma Ltd.
Form 483 issued October 13, 2023 · Sainte-Julie, Canada
- Inspection
- Oct 10 – Oct 13, 2023
- Investigator
- Jessica S. Estriplet
- Observations
- 4
- Pages
- 4
- FEI number
- 3003011816
In short: On October 13, 2023, FDA issued a Form 483 with 4 observations to Dermolab Pharma Ltd. in Sainte-Julie, Quebec (FEI 3003011816) after an inspection that ran Oct 10 – Oct 13, 2023. The investigator was Jessica S. Estriplet. Most observations concern quality system and production.
At a glance
3 of 4 observations on this 483 concern quality system.
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
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The quality control unit lacks the responsibility and authority to approve and reject all…
- 04
Written procedures are not established for evaluations conducted at least annually to review records associated with…
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 firmDermolab Pharma Ltd. 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 Dermolab Pharma Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Dermolab Pharma Ltd.?
Jessica S. Estriplet is named on this Form 483, for the inspection of Oct 10 – Oct 13, 2023. Each investigator has a profile showing what they cite most.
When was Dermolab Pharma Ltd. inspected by FDA?
The inspection ran Oct 10 – Oct 13, 2023, and the Form 483 is dated October 13, 2023.
How do I get the full Form 483 for Dermolab Pharma Ltd.?
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.