INDUSTRIA FARMACEUTICA GALENICA SENESE SRL
Form 483 issued May 4, 2021 · MONTERONI D'ARBIA, Italy
- Investigator
- Cynthia Jim
- Observations
- 3
- Pages
- 6
- FEI number
- 3006994492
In short: On May 4, 2021, FDA issued a Form 483 with 3 observations to INDUSTRIA FARMACEUTICA GALENICA SENESE SRL in MONTERONI D'ARBIA, Italy (FEI 3006994492). The investigator was Cynthia Jim. 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
Consistency and reproducibility has not been demonstrated in the man: Injection registration batches. i bag is…
- 02
Laboratory records do not include complete records of…
- 03
Time limits are not established when appropriate for the completion of each production phase…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmINDUSTRIA FARMACEUTICA GALENICA SENESE SRL history
All 2 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 INDUSTRIA FARMACEUTICA GALENICA SENESE SRL?
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 INDUSTRIA FARMACEUTICA GALENICA SENESE SRL?
Cynthia Jim is named on this Form 483. Each investigator has a profile showing what they cite most.
When was INDUSTRIA FARMACEUTICA GALENICA SENESE SRL inspected by FDA?
This Form 483 is dated May 4, 2021.
How do I get the full Form 483 for INDUSTRIA FARMACEUTICA GALENICA SENESE 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.