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•United States

BPI Labs LLC, Largo, FL – FDA Inspections

Inspection records and compliance data for BPI Labs LLC in Largo, Florida. 3 FDA inspections on record, 3 Form 483s, 1 warning letter, last inspected April 17, 2026.

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Company Profile

This profile covers BPI Labs LLC based in Largo, Florida, United States.

FDA Inspection History

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

First inspected February 21, 2025. Last inspected April 17, 2026.

Most cited issue areas

  • Bulk drug substances, cannot be used in compounding1 inspection
  • Drug product labels, fails to include1 inspection
  • Failure to comply with REMS Elements to Assure Safe Use (ETASU) A1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
April 17, 2026Not classifiedHuman Drugs · Drug Quality Assurance1312854
April 23, 2025VAIHuman Drugs · Postmarketing Surveillance and Epidemiology: Human Drugs1267652
February 21, 2025NAIHuman Drugs · Drug Quality Assurance1261584
FDA documents

Form 483s (4)

  • Form 483s · April 17, 2026
  • Form 483s · April 23, 2025
  • Form 483s · February 21, 2025
  • Form 483s · April 30, 2021

Warning Letters (1)

  • Warning Letters · March 25, 2025
People (5)
Jessica L. Pressley
Person
Emma Schaefer
Person
Logan T. Williams
Person
Nicole E. Knowlton
Person
Tina Smith
Person
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Company Information

Name

BPI Labs LLC

FEI Number

3015156709

Address

12395 S Belcher Rd, Largo, Florida 33773-3097, United States

Country

United States

ID: 3c43cb39-35d9-4866-83dc-7bc12ae51c8a

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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