FDA Inspection
FairyGene IncFairyGene Inc – FDA Inspection, Jan 15, 2026
Record Details
This FDA Inspection record concerns FairyGene Inc, with an inspection on January 15, 2026, issued by the Philadelphia District Office, covering human drugs.
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ID · 1a548a31-b8ad-4eed-868d-e62507b6b604
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1298534
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.67(b)Written procedures not established/followed
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