FDA Inspection
BioTissue Holdings IncBioTissue Holdings Inc – FDA Inspection, Sep 1, 2026
Record Details
This FDA Inspection record concerns BioTissue Holdings Inc, with an inspection on September 1, 2026, issued by the Florida District Office, covering biologics.
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ID · 2f1713bf-8719-4236-8d5b-c9006f742ec8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1312222
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(5)Testing of reconstituted drugs
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
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Other FDA inspections of BioTissue Holdings Inc
10| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| February 6, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for BioTissue Holdings Inc
- FDA Inspection 1304322 - 2026-02-18
- FDA Inspection 1230477 - 2024-03-06
- FDA Inspection 1101487 - 2019-08-15
- FDA Inspection 1096403 - 2019-07-16
- FDA Inspection 1040962 - 2018-02-06
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