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•United States

Surmasis Pharmaceutical, LLC, Des Moines, IA – FDA Inspections

Inspection records and compliance data for Surmasis Pharmaceutical, LLC in Des Moines, Iowa. 3 FDA inspections on record (1 OAI), 2 Form 483s, last inspected August 01, 2025.

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Company Profile

This profile covers Surmasis Pharmaceutical, LLC based in Des Moines, Iowa, United States.

FDA Inspection History

FDA inspections
3
OAI
1
VAI
2
NAI
0
Form 483s
2
Warning letters
0

First inspected March 1, 2018. Last inspected August 1, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Calibration/Inspection/Checking not done1 inspection
  • Complete test data included in records1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
August 1, 2025VAIHuman Drugs · Drug Quality Assurance1277270
March 19, 2020VAIHuman Drugs · Drug Quality Assurance1121169
March 1, 2018OAIHuman Drugs · Generic Drug Evaluation1042777
FDA documents

Form 483s (2)

  • Form 483s · August 1, 2025
  • Form 483s · March 19, 2020

EIRs (1)

  • EIRs · March 1, 2018
People (6)
Brett R. Havranek
Person
Michele L. Obert
Person
Peng Zhou
Person
Michele L. Glendenning
Person
Cecilia H. Kieu
Person
Aranjeet Singh
Person
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Company Information

Name

Surmasis Pharmaceutical, LLC

FEI Number

3011596846

Address

4020 Gannett Ave, Des Moines, Iowa 50321, United States

Country

United States

ID: 6f9dfe3c-c8c3-4740-b9a8-0ecc1bb9b400

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