FDA Inspection
LifeCell CorporationLifeCell Corporation – FDA Inspection, Jun 14, 2019
Record Details
This FDA Inspection record concerns LifeCell Corporation, with an inspection on June 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · be72417e-72ae-4bfd-b0f0-d068e8c12541
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1095091
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of LifeCell Corporation
12| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2026 | Not classified | New Jersey District Office | Human Cellular, Tissue, and Gene Therapies |
| May 21, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 20, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2019 | Not classified | New Jersey District Office | |
| September 27, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for LifeCell Corporation
- FDA Inspection 1329332 - 2026-09-21
- FDA Inspection 1230349 - 2024-05-21
- FDA Inspection 1120984 - 2020-02-20
- FDA Inspection 1089602 - 2019-01-10
- FDA Inspection 1028651 - 2017-09-27
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