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FDA establishment 3009809074, Doral, Florida, United States. Part of BioTissue Holdings, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 11
Official action indicated: 1
Last inspection ended: Sep 1, 2026
Warning letters: 0
Recalls since 2016: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
ISO 13485:2016 Clause 8.2.1. Information gathered in feedback process not used as input into risk management Information gathered in the feedback process does not adequately serve as potential input into risk management for monitoring and maintaining product requirements as well as the product realization or improvement processes.
ISO 13485:2016 Clause 8.5.2. Corrective action not taken Corrective action was not adequately taken to eliminate the cause of nonconformities in order to prevent recurrence.
21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of a device to meet any of its specifications were not evaluated where necessary.
21 CFR 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
21 CFR 803.50(a)(2). Individual Report of Malfunction An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
Voluntary Action Indicated (VAI)
Aug 15, 2019
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Jul 16, 2019
Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Biologics · Human Cellular, Tissue, and Gene Therapies
5 cited references
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately maintained.
21 CFR 820.90(b)(2). Product rework procedures, Lack of or inadequate procedures Procedures for rework of nonconforming product have not been adequately established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
Voluntary Action Indicated (VAI)
Feb 6, 2018
Biologics · Blood and Blood ProductsBiologics · Human Cellular, Tissue, and Gene Therapies
11 cited references
21 CFR 1271.210(a). Use prior to verification Supplies and reagents were used before they were verified to meet specifications designed to prevent the introduction, transmission, or spread of communicable disease.
21 CFR 1271.220(a). Causing contamination, increasing risks HCT/Ps were not processed in a way that does not cause contamination or cross contamination during processing and that does not increase the risk of introduction, transmission, or spread of communicable disease.
21 CFR 1271.195(b). Corrective actions Appropriate corrective actions were not taken related to the inspections of environmental control systems.
21 CFR 1271.200(a). Cleaned, sanitized per established schedules Equipment used for manufacturing HCT/Ps was not cleaned, sanitized and maintained according to established schedules.
21 CFR 1271.350(b)(2). Deviations not reported to FDA HCT/P deviations relating to core CGTP requirements that occurred in your establishment and at an establishment under contract, agreement, or arrangement with your establishment were not reported to FDA.
21 CFR 1271.47(a). Testing, screening, donor eligibility procedures Procedures for all steps performed in the screening of donor eligibility of HCT/Ps were not established and maintained.
21 CFR 1271.75(a)(1). Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for risk factors and clinical evidence of communicable disease agents and diseases.
21 CFR 1271.230(a). Validation & approval--established procedures Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures.
21 CFR 1271.220(c). Sampling representative (in-process HCT/Ps) Sampling of in-process HCT/Ps was not representative of the material to be evaluated.
21 CFR 1271.190(d)(2). Documentation of activities Documentation of facility cleaning and sanitation activities was not maintained.
21 CFR 1271.195(c). Monitoring--cross contamination, exposure to CD Environmental conditions are not monitored when such conditions could cause contamination or cross contamination of HCT/Ps or equipment.
Voluntary Action Indicated (VAI)
Oct 29, 2015
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Jul 7, 2015
Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices; Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Sep 25, 2014
Biologics · Human Cellular, Tissue, and Gene Therapies
None posted
No Action Indicated (NAI)
Dec 9, 2013
Biologics · Human Cellular, Tissue, and Gene TherapiesDevices · Postmarket Assurance: Devices; Devices · Compliance: Devices
1 cited reference
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
No Action Indicated (NAI)
Feb 12, 2010
Biologics · Human Cellular, Tissue, and Gene TherapiesDevices · Compliance: Devices; Devices · Postmarket Assurance: Devices
None posted
No Action Indicated (NAI)
Recalls
2 drug, device and biologic recalls since 2016, newest first; 0 Class I
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Doral, Florida, United States. Part of