FDA Inspection
QuestSpecialty CorporationQuestSpecialty Corporation – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns QuestSpecialty Corporation, with an inspection on June 12, 2025, issued by the Dallas District Office, covering human drugs.
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ID · 176987f1-f09f-4f0e-b975-c798a3db2545
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1272491
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
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Other FDA inspections of QuestSpecialty Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 14, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for QuestSpecialty Corporation
- FDA Inspection 1061339 - 2018-08-03
- FDA Inspection 1015214 - 2017-06-22
- FDA Inspection 735911 - 2011-07-22
- FDA Inspection 657077 - 2010-04-14
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