BSP Pharmaceuticals SpA
Form 483 issued March 31, 2022 · Latina Scalo, Italy
- Investigator
- Yasamin Ameri
- Observations
- 4
- Pages
- 2
- FEI number
- 3007255826
In short: On March 31, 2022, FDA issued a Form 483 with 4 observations to BSP Pharmaceuticals SpA in Latina Scalo, (LT) (FEI 3007255826). The investigator was Yasamin Ameri. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Complaint handling procedures describing the handling of written and oral complaint related to…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Input to and output from the computer, related systems of formulas, and records or data are…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmBSP Pharmaceuticals SpA history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSP Pharmaceuticals SpA?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected BSP Pharmaceuticals SpA?
Yasamin Ameri is named on this Form 483. Each investigator has a profile showing what they cite most.
When was BSP Pharmaceuticals SpA inspected by FDA?
This Form 483 is dated March 31, 2022.
How do I get the full Form 483 for BSP Pharmaceuticals SpA?
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.