FDA Inspection
BioTissue Holdings IncBioTissue Holdings Inc – FDA Inspection, Feb 6, 2018
Record Details
This FDA Inspection record concerns BioTissue Holdings Inc, with an inspection on February 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · adf9e664-a7c0-4ef7-a540-5973fcb81967
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040962
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 1271.195(b)Corrective actions
- 21 CFR 1271.190(d)(2)Documentation of activities
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.220(c)Sampling representative (in-process HCT/Ps)
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Other FDA inspections of BioTissue Holdings Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2026 | OAI | Florida District Office | Human Cellular, Tissue, and Gene Therapies |
| February 18, 2026 | VAI | Florida District Office | Compliance: Medical Devices |
| March 6, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 15, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 16, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for BioTissue Holdings Inc
- FDA Inspection 1312222 - 2026-09-01
- FDA Inspection 1304322 - 2026-02-18
- FDA Inspection 1230477 - 2024-03-06
- FDA Inspection 1101487 - 2019-08-15
- FDA Inspection 1096403 - 2019-07-16
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