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J. B. Chemicals and Pharmaceuticals Limited, Anklesvar, India – FDA Inspections

Inspection records and compliance data for J. B. Chemicals and Pharmaceuticals Limited in Anklesvar. 7 FDA inspections on record, 2 Form 483s, last inspected October 23, 2022.

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Company Profile

This profile covers J. B. Chemicals and Pharmaceuticals Limited based in Anklesvar, India.

FDA Inspection History

FDA inspections
7
OAI
0
VAI
4
NAI
2
Unclassified
1
Form 483s
2
Warning letters
0

First inspected December 2, 2011. Last inspected October 23, 2022.

Most cited issue areas

  • Control procedures to monitor and validate performance1 inspection
  • Procedures not in writing, fully followed1 inspection
  • Written in-process control procedures1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
October 23, 2022VAIHuman Drugs · Drug Quality Assurance1233390
February 7, 2020VAIHuman Drugs · Drug Quality Assurance1117757
October 18, 2018Not classifiedHuman Drugs1073375
August 24, 2018VAIHuman Drugs · Drug Quality Assurance1064488
June 24, 2016NAIHuman Drugs · Drug Quality Assurance978487
October 18, 2013VAIHuman Drugs · Drug Quality Assurance852629
December 2, 2011NAIHuman Drugs · Drug Quality Assurance762056
FDA documents

Form 483s (1)

  • Form 483s · February 7, 2020
People (1)
Nicole E. Knowlton
Person
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Noven Pharmaceuticals Inc
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Company Information

Name

J. B. Chemicals and Pharmaceuticals Limited

FEI Number

3003053502

Address

215 - 219 Gidc Industrial Area, Panoli, Anklesvar, India

Country

India

ID: d77ff966-bfe4-483b-8ca9-723a59fcaba5

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