FDA Inspection
QuestSpecialty CorporationQuestSpecialty Corporation – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns QuestSpecialty Corporation, with an inspection on August 3, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e66ddd2a-1852-4a45-91cc-5eda2a56fc42
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061339
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of QuestSpecialty Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | OAI | Dallas District Office | 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 1272491 - 2025-06-12
- FDA Inspection 1015214 - 2017-06-22
- FDA Inspection 735911 - 2011-07-22
- FDA Inspection 657077 - 2010-04-14
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