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LSNE-Leon, SLU, Leon, Spain – FDA Inspections

Inspection records and compliance data for LSNE-Leon, SLU in Leon. 4 FDA inspections on record, 2 Form 483s, last inspected March 21, 2024.

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Company Profile

This profile covers LSNE-Leon, SLU based in Leon, Spain.

FDA Inspection History

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

First inspected October 16, 2018. Last inspected March 21, 2024.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance1 inspection
  • Establish reliability of supplier's C of A1 inspection
  • Procedures not in writing, fully followed1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
March 21, 2024VAIHuman Drugs · Drug Quality Assurance1305290
September 19, 2023Not classifiedHuman Drugs1218601
May 28, 2021VAIHuman Drugs · Drug Quality Assurance1182019
October 16, 2018Not classifiedHuman Drugs1071007
FDA documents

Form 483s (2)

  • Form 483s · September 19, 2023
  • Form 483s · October 8, 2018

EIRs (2)

  • EIRs · January 17, 2020
  • EIRs · October 16, 2018
People (4)
Aditi S. Thakur
Person
Kham Phommachanh
Person
Adam R. Cooke
Person
Lareese K. Thomas
Person
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Shilpa Medicare Limited
Biocon Biologics Limited
Eugia Pharma Specialities Limited
Pharmathen International S.A.
Evonik Corporation
Eugia SEZ Private Limited
Company Information

Name

LSNE-Leon, SLU

FEI Number

3011566408

Address

Calle Nicostrato Vela S/N - M1.1-M1.2, Leon, Leon, Spain

Country

Spain

ID: 44b5bd66-624e-4c64-8c14-68139ec58183

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