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Phoenix Innovative Healthcare Manufacturers Private Limited, Navi Mumbai, India – FDA Inspections

Inspection records and compliance data for Phoenix Innovative Healthcare Manufacturers Private Limited in Navi Mumbai. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 27, 2024.

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Company Profile

This profile covers Phoenix Innovative Healthcare Manufacturers Private Limited based in Navi Mumbai, India.

FDA Inspection History

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

First inspected October 21, 2016. Last inspected September 27, 2024.

Most cited issue areas

  • Actual vs. theoretical yields not determined1 inspection
  • Equipment Design, Size and Location1 inspection
  • Investigations of discrepancies, failures1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
September 27, 2024OAIHuman Drugs · Drug Quality Assurance1250191
August 22, 2024NAIMedical Devices & Rad Health · Compliance: Devices1252466
September 27, 2019NAIHuman Drugs · Drug Quality Assurance1108987
October 21, 2016VAIHuman Drugs · Drug Quality Assurance993547
FDA documents

Form 483s (1)

  • Form 483s · September 27, 2024
People (1)
Steven A. Brettler
Person
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Company Information

Name

Phoenix Innovative Healthcare Manufacturers Private Limited

FEI Number

3010408344

Address

El - 209 Ttc Industrial Area, Shil Mahape Road Electronic Zone, Navi Mumbai, India

Country

India

ID: e8178194-701c-4e86-8bb8-0080fe10cf3f

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