Fisiopharma SRL
Form 483 issued September 27, 2019 · Palomonte, Italy
- Inspection
- Sep 19 – Sep 27, 2019
- Observations
- 10
- Pages
- 8
- FEI number
- 3006435023
In short: On September 27, 2019, FDA issued a Form 483 with 10 observations to Fisiopharma SRL in Palomonte, Salerno (FEI 3006435023) after an inspection that ran Sep 19 – Sep 27, 2019. Most observations concern production and quality system.
At a glance
Production and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 04
The control systems necessary to prevent contamination…
This inspection in context
Questions about this 483
What did FDA find at Fisiopharma SRL?
FDA listed 10 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Fisiopharma SRL inspected by FDA?
The inspection ran Sep 19 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Fisiopharma SRL?
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.