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•Italy

NerPharMa S.r.l., Nerviano, Italy – FDA Inspections

Inspection records and compliance data for NerPharMa S.r.l. in Nerviano. 11 FDA inspections on record, 4 Form 483s, last inspected June 27, 2025.

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Company Profile

This profile covers NerPharMa S.r.l. based in Nerviano, Italy.

FDA Inspection History

FDA inspections
11
OAI
0
VAI
5
NAI
2
Unclassified
4
Form 483s
4
Warning letters
0

First inspected October 30, 2009. Last inspected June 27, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Cleaning System1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (11)

DateResultFDA center(s)Insp. #
June 27, 2025Not classifiedHuman Drugs · Drug Quality Assurance1273996
September 13, 2024VAIHuman Drugs · Drug Quality Assurance1271174
June 19, 2024Not classifiedHuman Drugs1243307
February 20, 2023Not classifiedHuman Drugs1199864
January 17, 2020VAIHuman Drugs · Drug Quality Assurance1142104
October 26, 2018Not classifiedHuman Drugs1072258
June 1, 2017VAIHuman Drugs · Drug Quality Assurance1017090
March 5, 2015VAIHuman Drugs · Drug Quality Assurance920306
December 12, 2012NAIHuman Drugs · Drug Quality Assurance810163
July 19, 2010NAIHuman Drugs · Drug Quality Assurance676084
October 30, 2009VAIHuman Drugs · Drug Quality Assurance635650
FDA documents

Form 483s (3)

  • Form 483s · June 27, 2025
  • Form 483s · June 19, 2024
  • Form 483s

EIRs (1)

  • EIRs · February 20, 2023
People (5)
Lindsey S. Fleischman
Person
Cynthia Jim
Person
Daniel L Obstut
Person
Jeffrey P. Raimondi
Person
Eileen A. Liu
Person
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Takeda Pharmaceutical Company Limited
Advanced Accelerator Applications (Italy) srl
Shanghai Henlius Biopharmaceuticals Co., Ltd.
Company Information

Name

NerPharMa S.r.l.

FEI Number

3004762406

Address

Bldgs 65 And 71 Casella Postale N. 11, Viale Luigi Pasteur 10, Nerviano, Italy

Country

Italy

ID: 12f11f8a-e70e-4598-807c-a1571bab0391

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