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•United States

King Bio Inc., Asheville, NC – FDA Inspections

Inspection records and compliance data for King Bio Inc. in Asheville, North Carolina. 8 FDA inspections on record (1 OAI), 3 Form 483s, 2 warning letters, last inspected July 28, 2023.

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Company Profile

This profile covers King Bio Inc. based in Asheville, North Carolina, United States.

FDA Inspection History

FDA inspections
8
OAI
1
VAI
5
NAI
2
Form 483s
3
Warning letters
2

First inspected August 10, 2011. Last inspected July 28, 2023.

Most cited issue areas

  • Training , Education , Experience overall2 inspections
  • Active ingredient retained sample kept1 inspection
  • Batch production and Batch Control Record Requirements1 inspection

FDA inspections (8)

DateResultFDA center(s)Insp. #
July 28, 2023VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1215129
August 12, 2021VAIHuman Drugs · Drug Quality Assurance1149278
July 20, 2018OAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1059419
March 2, 2017VAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1004463
September 4, 2015VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices941497
October 15, 2014NAIHuman Drugs · Drug Quality Assurance900797
October 15, 2014NAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance900789
August 10, 2011VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices738907
FDA documents

Form 483s (2)

  • Form 483s · July 28, 2023
  • Form 483s · August 12, 2021

Warning Letters (2)

  • Warning Letters · July 20, 2018
  • Warning Letters
People (6)
Donald D. Ashley
Person
Mary K. Engle
Person
Charles D. Brown
Person
Shawn E. Larson
Person
Jared P. Stevens
Person
Bonita S. Chester
Person
Related Companies (10)

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

Altaire Pharmaceuticals, Inc.
Sentio Biosciences LLC
Zhejiang Jinhua Conba Bio-Pharm. Co., Ltd.
Hisun Pharmaceutical Hangzhou Co., Ltd
Church & Dwight Co., Inc.
Serumwerk Bernburg AG
OHM Pharma, Inc.
Les Importations Herbasante Inc.
Regis Technologies, Inc.
Eastman Chemical Company
Company Information

Name

King Bio Inc.

FEI Number

1053442

Address

3 Westside Dr, Asheville, North Carolina 28806, United States

Country

United States

ID: bad7278d-85cb-43ee-99a5-4cb9b13a45ea

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Contact
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