FDA Inspection
SV Labs Prescott CorporationSV Labs Prescott Corporation – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns SV Labs Prescott Corporation, with an inspection on September 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · aa521235-b313-49ee-b3e1-09c99cfd46f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067063
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
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Other FDA inspections of SV Labs Prescott Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 13, 2025 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 10, 2016 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 7, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 24, 2012 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for SV Labs Prescott Corporation
- FDA Inspection 1270932 - 2025-06-13
- FDA Inspection 969520 - 2016-03-10
- FDA Inspection 969519 - 2016-03-10
- FDA Inspection 866299 - 2014-02-07
- FDA Inspection 769962 - 2012-02-24
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