FDA Inspection
Life Science Outsourcing, Inc.Life Science Outsourcing, Inc. – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns Life Science Outsourcing, Inc., with an inspection on April 21, 2017, issued by the Los Angeles District Office, covering human drugs.
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ID · c72fa000-35f6-41f7-99bf-c18c1bbdee71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014994
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.160(b)(4)Written calibration procedures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Life Science Outsourcing, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| November 12, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Life Science Outsourcing, Inc.
- FDA Inspection 1294966 - 2025-12-11
- FDA Inspection 1132829 - 2020-11-12
- FDA Inspection 976086 - 2016-06-30
- FDA Inspection 871800 - 2014-03-20
- FDA Inspection 720864 - 2011-04-13
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