# FDA 483 - FairyGene Inc - January 15, 2026

Source: https://www.globalkeysolutions.net/records/483/fairygene-inc/fed8f78c-8644-4226-9b2a-b37cb70b822e

> FDA 483 for FairyGene Inc on January 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FairyGene Inc
- Inspection Date: 2026-01-15
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: FairyGene, Inc. in Bristol, PA, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in production and process controls, equipment cleaning, stability testing, facility design, and quality control unit procedures. These issues indicate a lack of adequate controls to ensure the quality and purity of their OTC drug products.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/christina-k-theodorou/3c18d958-14de-4f25-9fbd-7358205155f7)
- [Ofuje D. Daniyan](https://www.globalkeysolutions.net/people/ofuje-d-daniyan/8d7f5014-2a8a-4009-aef6-7e014df97b8b)

Company: https://www.globalkeysolutions.net/companies/fairygene-inc/d477479e-0b77-41db-bc58-1d6d38a14c09

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8