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Macleods Pharmaceuticals Limited, Daman, India – FDA Inspections

Inspection records and compliance data for Macleods Pharmaceuticals Limited in Daman. 5 FDA inspections on record, 3 Form 483s, last inspected May 26, 2023.

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Company Profile

This profile covers Macleods Pharmaceuticals Limited based in Daman, India.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
4
NAI
1
Form 483s
3
Warning letters
0

First inspected February 24, 2011. Last inspected May 26, 2023.

Most cited issue areas

  • Computer control of master formula records1 inspection
  • Equipment Design, Size and Location1 inspection
  • Procedures not in writing, fully followed1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
May 26, 2023VAIHuman Drugs · Drug Quality Assurance1206441
January 25, 2019VAIHuman Drugs · New Drug Evaluation1077302
May 29, 2017VAIHuman Drugs · Drug Quality Assurance1014132
November 15, 2013NAIHuman Drugs · Drug Quality Assurance859008
February 24, 2011VAIHuman Drugs · Drug Quality Assurance717278
FDA documents

Form 483s (1)

  • Form 483s · May 26, 2023
People (1)
Teresa I. Navas
Person
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LEO Pharma Ireland
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King Pharmaceuticals LLC
OrBion Pharmaceuticals Private Limited
Hikma Farmaceutica, (Portugal) S.A.
Company Information

Name

Macleods Pharmaceuticals Limited

FEI Number

3006363714

Address

Premier Industrial Estate Kachigam, Plot No 25-27, Survey No 366, Daman, India

Country

India

ID: 784654e5-6e07-47f7-9806-dd8c32db2e1d

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