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•United States

Afton Scientific, LLC, Charlottesville, VA – FDA Inspections

Inspection records and compliance data for Afton Scientific, LLC in Charlottesville, Virginia. 10 FDA inspections on record, 4 Form 483s, last inspected May 08, 2024.

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Company Profile

This profile covers Afton Scientific, LLC based in Charlottesville, Virginia, United States.

FDA Inspection History

FDA inspections
10
OAI
0
VAI
10
NAI
0
Form 483s
4
Warning letters
0

First inspected March 20, 2009. Last inspected May 8, 2024.

Most cited issue areas

  • Procedures not in writing, fully followed3 inspections
  • Absence of Written Procedures2 inspections
  • Procedures for sterile drug products2 inspections

FDA inspections (10)

DateResultFDA center(s)Insp. #
May 8, 2024VAIBiologics · Blood and Blood Products1237992
October 6, 2023VAIBiologics, Foods & Cosmetics · Foodborne Biological Hazards1219743
April 6, 2023VAIHuman Drugs · Drug Quality Assurance1202143
June 14, 2019VAIHuman Drugs · Drug Quality Assurance1092986
September 15, 2017VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices1025744
May 1, 2015VAIHuman Drugs · Drug Quality Assurance924691
April 25, 2014VAIHuman Drugs · Drug Quality Assurance875687
June 24, 2013VAIHuman Drugs · Drug Quality Assurance837211
September 26, 2011VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance746549
March 20, 2009VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance573864
FDA documents

Form 483s (4)

  • Form 483s · October 6, 2023
  • Form 483s · April 6, 2023
  • Form 483s · October 22, 2021
  • Form 483s · June 14, 2019

EIRs (1)

  • EIRs · June 14, 2019
Other regulators (1)
  • UK MHRA · 1 inspection · last September 23, 2010
People (4)
Gayle S. Lawson
Person
William Leonard
Person
Kristina L. Conroy
Person
Saleem A. Akhtar
Person
Related Companies (10)

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DPT Laboratories, Ltd
Patheon Manufacturing Services LLC
Pfizer Manufacturing Belgium NV
Bushu Pharmaceuticals Ltd.
Bora Pharmaceuticals Injectables Inc
Hospira, Inc., A Pfizer Company
Denison Pharmaceuticals, LLC
Company Information

Name

Afton Scientific, LLC

FEI Number

1000123236

Address

2020 Avon Ct, Charlottesville, Virginia 22902, United States

Country

United States

ID: e5ec92fc-2eb5-4366-8d78-fd597c977fe8

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Contact
New York Office:
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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