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Pharmaplast S.A.E., Alexandria, Egypt – FDA Inspections

Inspection records and compliance data for Pharmaplast S.A.E. in Alexandria, -. 2 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected February 06, 2025.

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Company Profile

This profile covers Pharmaplast S.A.E. based in Alexandria, Egypt.

FDA Inspection History

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

First inspected November 10, 2022. Last inspected February 6, 2025.

Most cited issue areas

  • Approve or reject components, products1 inspection
  • Batch production and Batch Control Record Requirements1 inspection
  • Complete test data included in records1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
February 6, 2025OAIHuman Drugs · Drug Quality Assurance1260910
November 10, 2022OAIHuman Drugs · Drug Quality Assurance1190349
FDA documents

Form 483s (2)

  • Form 483s · February 6, 2025
  • Form 483s · November 10, 2022

Warning Letters (1)

  • Warning Letters · November 10, 2022
People (3)
Michael A. Charles
Person
Francis Godwin
Person
Arsen Karapetyan
Person
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ACI HealthCare Limited
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Havix Group Inc
SHILPA MEDICARE LIMITED
Company Information

Name

Pharmaplast S.A.E.

FEI Number

3003767891

Address

Alexandria, - -, Egypt

Country

Egypt

ID: 69fdda1e-d63c-4bd4-b5ed-402c137267a5

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