FDA Inspection
Lifecore Biomedical LLCLifecore Biomedical LLC – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Lifecore Biomedical LLC, with an inspection on March 2, 2017, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 90afcd44-8223-4094-a809-fb74f26741f6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1007013
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Lifecore Biomedical LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2025 | VAI | Minneapolis District Office | Drug Quality Assurance |
| February 26, 2019 | Not classified | Minneapolis District Office | |
| February 26, 2019 | OAI | Center for Drug Evaluation and Research | New Drug Evaluation |
| August 7, 2017 | Not classified | Minneapolis District Office | |
| August 7, 2017 | Not classified | Minneapolis District Office |
Other documents for Lifecore Biomedical LLC
- FDA Inspection 1252478 - 2025-03-12
- FDA Inspection 1086140 - 2019-02-26
- FDA Inspection 1082292 - 2019-02-26
- FDA Inspection 1022753 - 2017-08-07
- FDA Inspection 1022752 - 2017-08-07
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