FDA Inspection
Lannett Company LLCLannett Company LLC – FDA Inspection, Oct 31, 2012
Record Details
This FDA Inspection record concerns Lannett Company LLC, with an inspection on October 31, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lannett Company LLC
- Inspection Date
- October 31, 2012
- Product Type
- Drugs
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ID · 8ceffdfe-74b2-4676-b375-fcd906ce8ce2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 805706
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Lannett Company LLC
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2026 | Not classified | Detroit District Office | Drug Quality Assurance |
| October 21, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 2, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lannett Company LLC
- FDA Inspection 1327406 - 2026-08-21
- FDA Inspection 1187299 - 2022-10-21
- FDA Inspection 1060761 - 2018-07-23
- FDA Inspection 1040079 - 2018-02-02
- FDA Inspection 907339 - 2014-12-16
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