Drug factory · FDA FEI 1000115753
Lifecore Biomedical, LLC
3515 Lyman Blvd, Chaska, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 12, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2015: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine and Meloxicam | Makes it | Heron Therapeutics, Inc. | 47426-301, 47426-302, 47426-303 +5 |
| Granisetron | Makes it, tests it, packages it and labels it | Heron Therapeutics, Inc. | 47426-101 |
| Pegcetacoplan | Makes it | Apellis Pharmaceuticals, Inc. | 73606-020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 12, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 26, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 12, 2025 inspection
- Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.