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•United States

FairyGene Inc, Bristol, PA – FDA Inspections

Inspection records and compliance data for FairyGene Inc in Bristol, Pennsylvania. 1 FDA inspection on record (1 OAI), 1 Form 483, 1 warning letter, last inspected January 15, 2026.

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Company Profile

This profile covers FairyGene Inc based in Bristol, Pennsylvania, United States.

FDA Inspection History

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

Inspected January 15, 2026.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Adequate space lacking to prevent mix-ups and contamination1 inspection
  • Lack of written stability program1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
January 15, 2026OAIHuman Drugs · Drug Quality Assurance1298534
FDA documents

Form 483s (1)

  • Form 483s · January 15, 2026

Warning Letters (1)

  • Warning Letters · January 15, 2026
People (4)
Christina K. Theodorou
Person
Ofuje D. Daniyan
Person
Francis Godwin
Person
Tina Smith
Person
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Company Information

Name

FairyGene Inc

FEI Number

3023594691

Address

2 Pearl Buck Ct Ste 1, Bristol, Pennsylvania, United States

Country

United States

ID: d477479e-0b77-41db-bc58-1d6d38a14c09

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