INDUSTRIA FARMACEUTICA GALENICA SENESE SRL
Form 483 issued July 1, 2022 · MONTERONI D'ARBIA, Italy
- Inspection
- Jun 23 – Jul 1, 2022
- Investigator
- Alan P. Kurtzberg
- Observations
- 2
- Pages
- 2
- FEI number
- 3006994492
In short: On July 1, 2022, FDA issued a Form 483 with 2 observations to INDUSTRIA FARMACEUTICA GALENICA SENESE SRL in MONTERONI D'ARBIA, Italy (FEI 3006994492) after an inspection that ran Jun 23 – Jul 1, 2022. The investigator was Alan P. Kurtzberg. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
Master production and control records lack complete manufacturing and control instructions, sampling and…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.192
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 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected INDUSTRIA FARMACEUTICA GALENICA SENESE SRL?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Jun 23 – Jul 1, 2022. Each investigator has a profile showing what they cite most.
When was INDUSTRIA FARMACEUTICA GALENICA SENESE SRL inspected by FDA?
The inspection ran Jun 23 – Jul 1, 2022, and the Form 483 is dated July 1, 2022.
How do I get the full Form 483 for INDUSTRIA FARMACEUTICA GALENICA SENESE SRL?
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