FDA Inspection
Lannett Company LLCLannett Company LLC – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Lannett Company LLC, with an inspection on February 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Emilie Kahn (Issuing Officer)
- Emily J. Stoklosa (Issuing Officer)
View Company Profile
ID · 2e3e9ddd-a3d0-4032-b844-df09c075f576
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
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 |
| December 16, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 15, 2013 | 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 907339 - 2014-12-16
- FDA Inspection 844613 - 2013-08-15
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.