BSP Pharmaceuticals SpA
FDA inspection history in Latina Scalo, Italy, 2018 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Latina Scalo, Italy.
- 2022–24Two Form 483s, at Latina Scalo, Italy.
- 2022The longest 483 on file: 4 observations over 2 pages at Latina Scalo, Italy.
Cited most
Across all BSP Pharmaceuticals SpA observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.198Complaint files1
The complete BSP Pharmaceuticals SpA file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Latina Scalo, Italy
Three Form 483s · 2018 to 2024 · 9 observations
Latest: Form 483, Feb 29, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-29 | 483 Form 483 | Latina Scalo, Italy | 2 | $99 |
| 2022-03-31 | 483 Form 483 | Latina Scalo, Italy | 4 | $99 |
| 2018-09-21 | 483 Form 483 | Latina Scalo, Italy | 3 | $99 |
Investigators on these documents
Deborah Schmiel (1)Ephrem Hunde (1)Ere Hankins (1)Yasamin Ameri (1)
FEI number 3007255826 · most recent document Feb 29, 2024
About BSP Pharmaceuticals SpA
How many FDA Form 483s has BSP Pharmaceuticals SpA received?
FDA Intel has 3 Form 483s on file for BSP Pharmaceuticals SpA; the most recent is dated Feb 29, 2024.
When was BSP Pharmaceuticals SpA last inspected by FDA?
The most recent FDA inspection document on file for BSP Pharmaceuticals SpA is a Form 483 dated Feb 29, 2024, for the site in Latina Scalo, Italy.
What did FDA cite at BSP Pharmaceuticals SpA?
The regulations cited most in the observations on file for BSP Pharmaceuticals SpA are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.