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•United States

Apex Pharmaceuticals Inc., South Plainfield, NJ – FDA Inspections

Inspection records and compliance data for Apex Pharmaceuticals Inc. in South Plainfield, New Jersey. 2 FDA inspections on record, 2 Form 483s, last inspected April 18, 2019.

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Company Profile

This profile covers Apex Pharmaceuticals Inc. based in South Plainfield, New Jersey, United States.

FDA Inspection History

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

First inspected November 8, 2016. Last inspected April 18, 2019.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance1 inspection
  • GMP Training Frequency1 inspection
  • Scientifically sound laboratory controls1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
April 18, 2019VAIHuman Drugs · Drug Quality Assurance1086635
November 8, 2016Not classifiedHuman Drugs995863
FDA documents

Form 483s (1)

  • Form 483s · April 18, 2019
People (1)
Unnee Ranjan
Person
Related Companies (10)

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Mitsubishi Tanabe Pharma Development America, Inc.
Nimesh P. Nagarsheth, M.D.
Gregory J. Tracey, M.D.
Wockhardt USA LLC
Company Information

Name

Apex Pharmaceuticals Inc.

FEI Number

3006719767

Address

3005 Hadley Rd Ste 8, South Plainfield, New Jersey 07080, United States

Country

United States

ID: 6e156f16-7c9b-40b7-a267-0c315ab67b38

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