BSP Pharmaceuticals SpA
Form 483 issued September 21, 2018 · Latina Scalo, Italy
- Investigators
- Ephrem Hunde· Ere Hankins
- Observations
- 3
- Pages
- 1
- FEI number
- 3007255826
In short: On September 21, 2018, FDA issued a Form 483 with 3 observations to BSP Pharmaceuticals SpA in Latina Scalo, (LT) (FEI 3007255826). The investigators were Ephrem Hunde and Ere Hankins. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are discrepancies between the information included in the and the operations at…
- 02
Pressure monitored during routine of the drug product is not representative of the pressure validated during…
- 03
Procedure QC-001 for Management of Out of Specification and…
This inspection in context
Ephrem Hunde
3 documents · 2016–2018
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSP Pharmaceuticals SpA?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected BSP Pharmaceuticals SpA?
Ephrem Hunde and Ere Hankins are 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 September 21, 2018.
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.