INDUSTRIA FARMACEUTICA GALENICA SENESE SRL
FDA inspection history in MONTERONI D'ARBIA, Italy, 2021 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22Two Form 483s, at MONTERONI D'ARBIA, Italy.
- 2022The longest 483 on file: 2 observations over 2 pages at MONTERONI D'ARBIA, Italy.
Cited most
Across all INDUSTRIA FARMACEUTICA GALENICA SENESE SRL observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.192Production record review1
The complete INDUSTRIA FARMACEUTICA GALENICA SENESE SRL file.
All 2 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
MONTERONI D'ARBIA, Italy
Two Form 483s · 2021 to 2022 · 2 observations
Latest: Form 483, Jul 1, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-01 | 483 Form 483 | MONTERONI D'ARBIA, Italy | 2 | $99 |
| 2021-05-04 | 483 Form 483 | MONTERONI D'ARBIA, Italy | — | $99 |
Investigators on these documents
FEI number 3006994492 · most recent document Jul 1, 2022
About INDUSTRIA FARMACEUTICA GALENICA SENESE SRL
How many FDA Form 483s has INDUSTRIA FARMACEUTICA GALENICA SENESE SRL received?
FDA Intel has 2 Form 483s on file for INDUSTRIA FARMACEUTICA GALENICA SENESE SRL; the most recent is dated Jul 1, 2022.
When was INDUSTRIA FARMACEUTICA GALENICA SENESE SRL last inspected by FDA?
The most recent FDA inspection document on file for INDUSTRIA FARMACEUTICA GALENICA SENESE SRL is a Form 483 dated Jul 1, 2022, for the site in MONTERONI D'ARBIA, Italy.
What did FDA cite at INDUSTRIA FARMACEUTICA GALENICA SENESE SRL?
The regulations cited most in the observations on file for INDUSTRIA FARMACEUTICA GALENICA SENESE SRL are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.166 (Stability testing), 1 time.