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  5. Bora Pharmaceuticals Inc. (OTC: BORAY), Maple Grove, MN – FDA Inspections
Company
•United States•Public company, OTC: BORAY

Bora Pharmaceuticals Inc. (OTC: BORAY), Maple Grove, MN – FDA Inspections

Inspection records and compliance data for Bora Pharmaceuticals Inc. in Maple Grove, Minnesota. 16 FDA inspections on record (1 OAI), 3 Form 483s, last inspected July 11, 2024. Publicly traded as OTC: BORAY.

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Company Profile

This profile covers Bora Pharmaceuticals Inc. based in Maple Grove, Minnesota, United States.

FDA Inspection History

FDA inspections
16
OAI
1
VAI
6
NAI
8
Unclassified
1
Form 483s
3
Warning letters
0

First inspected October 2, 2008. Last inspected July 11, 2024.

Most cited issue areas

  • Cleaning SOPs/schedules1 inspection
  • Identification of each component or in-process material1 inspection
  • Personnel dating/signing equipment log1 inspection

FDA inspections (16)

DateResultFDA center(s)Insp. #
July 11, 2024Not classifiedHuman Drugs1242169
November 3, 2022NAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ1191488
August 30, 2022VAIHuman Drugs · Drug Quality Assurance1178557
December 19, 2018NAIFoods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ1075923
December 19, 2018VAIFoods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ1075922
June 21, 2018NAIHuman Drugs · Bioresearch Monitoring1057809
December 10, 2015NAIHuman Drugs · Drug Quality Assurance957264
December 10, 2015NAIHuman Drugs · Drug Quality Assurance957263
March 3, 2014VAIFoods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ869641
March 1, 2013VAIHuman Drugs · Drug Quality Assurance822479
March 1, 2013VAIHuman Drugs · Drug Quality Assurance822477
February 28, 2011NAIHuman Drugs · Drug Quality Assurance711370
February 22, 2011VAIHuman Drugs · Drug Quality Assurance711848
October 8, 2010OAIFoods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ684684
September 29, 2010NAIHuman Drugs · Drug Quality Assurance684686
October 2, 2008NAIHuman Drugs · Drug Quality Assurance539836
FDA documents

Form 483s (3)

  • Form 483s · July 11, 2024
  • Form 483s · August 30, 2022
  • Form 483s · December 19, 2018

EIRs (1)

  • EIRs · June 21, 2018
People (5)
Kellie L. Thommes
Person
Courtney R. Ingalsbe
Person
Ross J. Grigsby
Person
Zoyinka P Fuenay
Person
Kevin P. Regan
Person
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Company Information

Name

Bora Pharmaceuticals Inc.

Stock ticker

BORAY

Exchange

OTC

Price as of

November 13, 2026

FEI Number

3004106442

Address

6701 Evenstad Dr N, Maple Grove, Minnesota 55369, United States

Country

United States

ID: e13118d8-e5af-4804-95e0-42699dfbf333

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