FDA Inspection 1298534 — FairyGene, Inc.
The FDA completed an inspection of FairyGene, Inc. on Jan 15, 2026 in Bristol, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 15, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bristol, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |