FDA Inspection
Everest Life Sciences LLCEverest Life Sciences LLC – FDA Inspection, Apr 23, 2025
Record Details
This FDA Inspection record concerns Everest Life Sciences LLC, with an inspection on April 23, 2025, issued by the New Jersey District Office, covering human drugs.
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ID · c8c57801-5139-4351-b5c2-5a1ba452bda1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1267697
- 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 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Everest Life Sciences LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 23, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 13, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 16, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Everest Life Sciences LLC
- FDA Inspection 1071273 - 2018-10-23
- FDA Inspection 1063269 - 2018-07-13
- FDA Inspection 964002 - 2016-03-16
- FDA Inspection 778012 - 2012-04-16
- FDA Inspection 710185 - 2011-02-18
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