FDA Inspection
Scientech Laboratories IncScientech Laboratories Inc – FDA Inspection, Feb 24, 2010
Record Details
This FDA Inspection record concerns Scientech Laboratories Inc, with an inspection on February 24, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Scientech Laboratories Inc
- Inspection Date
- February 24, 2010
- Product Type
- Veterinary
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ID · a7789ce5-d783-46e9-8080-405d49ca29ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 646635
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
8- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
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Other FDA inspections of Scientech Laboratories Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 19, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 25, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 23, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 25, 2013 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Scientech Laboratories Inc
- FDA Inspection 1200004 - 2023-03-03
- FDA Inspection 1038027 - 2018-01-19
- FDA Inspection 1012438 - 2017-04-25
- FDA Inspection 911456 - 2015-01-23
- FDA Inspection 830240 - 2013-04-25
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