FDA Inspection
LifeCell CorporationLifeCell Corporation – FDA Inspection, Aug 25, 2017
Record Details
This FDA Inspection record concerns LifeCell Corporation, with an inspection on August 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f5d55f95-83c7-4ed8-a31d-623c5d6977bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023275
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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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 |
| June 14, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2019 | Not classified | New Jersey District Office |
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 1095091 - 2019-06-14
- FDA Inspection 1089602 - 2019-01-10
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