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•United States

Granules Pharmaceuticals Inc., Chantilly, VA – FDA Inspections

Inspection records and compliance data for Granules Pharmaceuticals Inc. in Chantilly, Virginia. 8 FDA inspections on record, 6 Form 483s, last inspected April 03, 2026.

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Company Profile

This profile covers Granules Pharmaceuticals Inc. based in Chantilly, Virginia, United States.

FDA Inspection History

FDA inspections
8
OAI
0
VAI
6
NAI
1
Unclassified
1
Form 483s
6
Warning letters
0

First inspected December 8, 2017. Last inspected April 3, 2026.

Most cited issue areas

  • Buildings not maintained in good state of repair2 inspections
  • Equipment Design, Size and Location2 inspections
  • Procedures not in writing, fully followed2 inspections

FDA inspections (8)

DateResultFDA center(s)Insp. #
April 3, 2026VAIHuman Drugs · Drug Quality Assurance1311002
June 27, 2025VAIHuman Drugs · Generic Drug Evaluation1274604
December 15, 2023VAIHuman Drugs · Drug Quality Assurance1225087
August 3, 2023NAIHuman Drugs · Bioresearch Monitoring1215034
July 22, 2022VAIHuman Drugs · Drug Quality Assurance1175097
August 21, 2019Not classifiedHuman Drugs1107374
October 26, 2018VAIHuman Drugs · Generic Drug Evaluation1069969
December 8, 2017VAIHuman Drugs · Drug Quality Assurance1035023
FDA documents

Form 483s (10)

  • Form 483s · April 3, 2026
  • Form 483s · June 27, 2025
  • Form 483s · December 15, 2023
  • Form 483s · July 22, 2022
  • Form 483s · January 28, 2022
  • Form 483s · June 25, 2021
  • Form 483s · January 17, 2020
  • Form 483s · August 21, 2019
  • Form 483s · October 26, 2018
  • Form 483s · December 8, 2017

EIRs (1)

  • EIRs · January 28, 2022
People (3)
Craig D. Zagata
Person
Zhong Li
Person
Amy Wang
Person
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Company Information

Name

Granules Pharmaceuticals Inc.

FEI Number

3011585184

Address

3701 Concorde Pkwy, Chantilly, Virginia 20151, United States

Country

United States

ID: fa93bf3f-822e-47be-9e47-59b1c5446629

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Contact
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