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•United States

PediFix, Inc., Brewster, NY – FDA Inspections

Inspection records and compliance data for PediFix, Inc. in Brewster, New York. 4 FDA inspections on record, last inspected February 12, 2024.

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Company Profile

This profile covers PediFix, Inc. based in Brewster, New York, United States.

FDA Inspection History

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

First inspected April 7, 2010. Last inspected February 12, 2024.

Most cited issue areas

  • Annual visual exams of drug products1 inspection
  • Computer control of master formula records1 inspection
  • Contract drug products--lack of responsibility1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
February 12, 2024VAIHuman Drugs · Drug Quality Assurance1229332
October 13, 2015NAIHuman Drugs · Drug Quality Assurance945810
November 15, 2011NAIHuman Drugs · Drug Quality Assurance753558
April 7, 2010NAIHuman Drugs · Drug Quality Assurance655612
FDA documents

Form 483s (1)

  • Form 483s · February 12, 2024
People (1)
Syeda N. Mahazabin
Person
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Company Information

Name

PediFix, Inc.

FEI Number

3009710062

Address

301 Fields Ln, Brewster, New York 10509, United States

Country

United States

ID: 7a6cb7c8-fc8a-42c1-8b8a-7ea5fdd7a346

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