FDA Inspection
Lifecore Biomedical LLCLifecore Biomedical LLC – FDA Inspection, Feb 26, 2019
Record Details
This FDA Inspection record concerns Lifecore Biomedical LLC, with an inspection on February 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 21535ca5-e17b-4595-aabe-a84a7bc033cd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1082292
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.110(b)In-process materials specifications testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.84(d)(3)Establish reliability of supplier's C of A
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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 | |
| August 7, 2017 | Not classified | Minneapolis District Office | |
| August 7, 2017 | Not classified | Minneapolis District Office | |
| March 2, 2017 | OAI | Minneapolis District Office | Project Evaluation: Devices |
Other documents for Lifecore Biomedical LLC
- FDA Inspection 1252478 - 2025-03-12
- FDA Inspection 1086140 - 2019-02-26
- FDA Inspection 1022753 - 2017-08-07
- FDA Inspection 1022752 - 2017-08-07
- FDA Inspection 1008554 - 2017-03-02
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