FDA Inspection 1272491 — QuestSpecialty Corporation
The FDA completed an inspection of QuestSpecialty Corporation on Jun 12, 2025 in Brenham, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brenham, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |