FDA establishment 3007793449, Houston, Texas, United States. Part of Pensar Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
ISO 13485:2016 Clause 8.5.2: Corrective action procedures not documented1
ISO 13485:2016 Clause 7.3.9: Requirements for design and development changes not met before implementation1
ISO 13485:2016 Clause 7.3.6: Records of design and development verification not maintained1
ISO 13485:2016 Clause 7.3.4: Records of design and development outputs not maintained1
ISO 13485:2016 Clause 4.1.2: Risk-based approach not applied to QMS processes1
Inspections
4 inspections, newest first
Ended
Product and area
Citations
Classification
Apr 28, 2026
Devices · Compliance: Devices
7 cited references
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for timely and effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, planning and documenting action needed and implementing such action, verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device and reviewing the effectiveness of corrective action taken have not been adequately documented.
ISO 13485:2016 Clause 7.3.9. Requirements for design and development changes not met before implementation Design and development changes were not adequately reviewed, verified, validated, and approved before implementation.
ISO 13485:2016 Clause 7.3.6. Records of design and development verification not maintained Records of the results and conclusions of design and development verification and necessary actions were not adequately maintained.
ISO 13485:2016 Clause 7.3.4. Records of design and development outputs not maintained Records of design and development outputs were not adequately maintained.
ISO 13485:2016 Clause 4.1.2. Risk-based approach not applied to QMS processes A risk-based approach to the control of the appropriate processes needed for the quality management system has not been adequately applied.
ISO 13485:2016 Clause 8.2.2. Complaint handling procedures lack required elements Procedures for timely complaint handling do not adequately include requirements and responsibilities for investigating complaints, determining the need to report the information to FDA, handling of complaint-related product and determining the need to initiate corrections or corrective actions.
21 CFR 820.75(c). Process changes - review, evaluation and revalidation A validated process was not revalidated when changes or process deviations occurred.
21 CFR 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable consultants have not been established.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.72(a). Equipment control activity documentation Equipment inspections, checks and maintenance activities have not been documented.
21 CFR 820.30(j). Design history file The design history file was not established.
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 investigated where necessary.
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 documented.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been adequately established to control product that does not conform to specified requirements.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
Voluntary Action Indicated (VAI)
Warning Letters
Letters naming this establishment; each opens the letter
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. 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 and warning letters
Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
