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Company
•United States

Artesanales P.R. LLC, Bayamon, PR – FDA Inspections

Inspection records and compliance data for Artesanales P.R. LLC in Bayamon, Puerto Rico. 2 FDA inspections on record (2 OAI), 2 Form 483s, last inspected January 22, 2025.

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Company Profile

This profile covers Artesanales P.R. LLC based in Bayamon, Puerto Rico, United States.

FDA Inspection History

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

First inspected October 23, 2023. Last inspected January 22, 2025.

Most cited issue areas

  • Lack of quality control unit1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
January 22, 2025OAIHuman Drugs · Drug Quality Assurance1239023
October 23, 2023OAIHuman Drugs · Drug Quality Assurance1221439
FDA documents

Form 483s (2)

  • Form 483s · January 22, 2025
  • Form 483s · October 23, 2023
People (3)
Angelica M. Hernandez
Person
Marian E. Ramirez
Person
Christian F. Gomez Lugo
Person
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Massimo Cristofanilli, MD
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Company Information

Name

Artesanales P.R. LLC

FEI Number

3017125065

Address

D St Local 3 Minillas Industrial Park, Bayamon, Puerto Rico 00959, United States

Country

United States

ID: 0f009db9-0b57-4983-94fa-b929674aab83

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