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  5. Exela Pharma Sciences LLC, Lenoir, NC – FDA Inspections
Company
•United States

Exela Pharma Sciences LLC, Lenoir, NC – FDA Inspections

Inspection records and compliance data for Exela Pharma Sciences LLC in Lenoir, North Carolina. 14 FDA inspections on record (1 OAI), 5 Form 483s, 2 warning letters, last inspected November 15, 2024.

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Company Profile

This profile covers Exela Pharma Sciences LLC based in Lenoir, North Carolina, United States.

FDA Inspection History

FDA inspections
14
OAI
1
VAI
6
NAI
6
Unclassified
1
Form 483s
5
Warning letters
2

First inspected December 10, 2010. Last inspected November 15, 2024.

Most cited issue areas

  • Environmental Monitoring System3 inspections
  • Calibration/Inspection/Checking not done2 inspections
  • Prepared for each batch, include complete information2 inspections

FDA inspections (14)

DateResultFDA center(s)Insp. #
November 15, 2024OAIHuman Drugs · Drug Quality Assurance1256957
July 18, 2019VAIHuman Drugs · Drug Quality Assurance1096634
March 29, 2019VAIHuman Drugs · Generic Drug Evaluation1084304
December 19, 2018NAIHuman Drugs · Drug Quality Assurance1081405
September 11, 2018NAIHuman Drugs · Bioresearch Monitoring1067755
October 27, 2017Not classifiedHuman Drugs1032076
September 28, 2017VAIHuman Drugs · Drug Quality Assurance1026858
June 8, 2016NAIHuman Drugs · Drug Quality Assurance988490
November 21, 2014VAIHuman Drugs · Drug Quality Assurance906470
August 28, 2014NAIHuman Drugs · Drug Quality Assurance893626
April 12, 2013NAIHuman Drugs · Drug Quality Assurance849770
January 20, 2012NAIHuman Drugs · Drug Quality Assurance766906
September 2, 2011VAIHuman Drugs · Drug Quality Assurance750589
December 10, 2010VAIHuman Drugs · Drug Quality Assurance701088
FDA documents

Form 483s (5)

  • Form 483s · November 4, 2024
  • Form 483s · July 18, 2019
  • Form 483s · March 29, 2019
  • Form 483s · September 28, 2017
  • Form 483s · November 21, 2014

Warning Letters (2)

  • Warning Letters · November 15, 2024
  • Warning Letters · July 18, 2019

EIRs (3)

  • EIRs · October 22, 2019
  • EIRs · July 18, 2019
  • EIRs · December 19, 2018
People (6)
Noreen Muniz
Person
Brett Weed
Person
Samantha J. Bradley
Person
Jason R. Caballero
Person
John Mazza
Person
Baron Bowers
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

SUNNY PHARMTECH INC.
Shandong New Time Pharmaceutical Co. Ltd.
Kashiv BioSciences, LLC
Glenmark Pharmaceuticals Inc USA
GlaxoSmithKline, LLC.
Gland Pharma Limited
Fujian Genohope Biotech Ltd.
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
Amneal Oncology Private Limited
Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (FDF Site)
Company Information

Name

Exela Pharma Sciences LLC

FEI Number

3008563008

Address

1245 Blowing Rock Blvd, Lenoir, North Carolina 28645, United States

Country

United States

ID: 4e6f3b32-adeb-41f4-b9dd-a8e7784569b3

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