BSP Pharmaceuticals SpA
Form 483 issued February 29, 2024 · Latina Scalo, Italy
- Investigator
- Deborah Schmiel
- Observations
- 2
- Pages
- 1
- FEI number
- 3007255826
In short: On February 29, 2024, FDA issued a Form 483 with 2 observations to BSP Pharmaceuticals SpA in Latina Scalo, (LT) (FEI 3007255826). The investigator was Deborah Schmiel. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel monitoring is…
- 02
Indirect product contact surfaces used in aseptic drug product filling operations…
This inspection in context
Deborah Schmiel
5 documents · 2016–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in South Korea.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BSP Pharmaceuticals SpA?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected BSP Pharmaceuticals SpA?
Deborah Schmiel 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 February 29, 2024.
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.