FDA Inspection
QuestSpecialty CorporationQuestSpecialty Corporation – FDA Inspection, Apr 14, 2010
Record Details
This FDA Inspection record concerns QuestSpecialty Corporation, with an inspection on April 14, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- QuestSpecialty Corporation
- Inspection Date
- April 14, 2010
- Product Type
- Drugs
View Company Profile
ID · eded620f-9240-40b3-8f10-d3519eb30026
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 657077
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.122(a)Written procedures not 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 |
| 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 |
Other documents for QuestSpecialty Corporation
- FDA Inspection 1272491 - 2025-06-12
- FDA Inspection 1061339 - 2018-08-03
- FDA Inspection 1015214 - 2017-06-22
- FDA Inspection 735911 - 2011-07-22
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