FDA Inspection
Lernapharm (Loris) Inc.Lernapharm (Loris) Inc. – FDA Inspection, Dec 12, 2017
Record Details
This FDA Inspection record concerns Lernapharm (Loris) Inc., with an inspection on December 12, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 689e3694-451f-4ed2-9d31-6002bc7b4e66
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1034584
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.115(a)Reprocessing procedures not written or followed
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of Lernapharm (Loris) Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 6, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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