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FDA establishment 1000121696, North Brunswick, New Jersey, United States. Part of LeMaitre Vascular's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 8
Official action indicated: 3
Last inspection ended: Jun 25, 2026
Warning letters: 1
Recalls since 2016: 4
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 8.5.3. Preventive action procedures not documented Preventive action procedures describing the requirements for planning and documenting action needed and implementing such action have not been adequately documented.
ISO 13485:2016 Clause 7.3.3. Design and development inputs do not include all requirements Design and development inputs related to product requirements do not adequately include requirements essential for design and development of the product and processes.
ISO 13485:2016 Clause 7.5.11. Procedures for preserving the conformity of product not documented Procedures were not adequately documented for preserving the conformity of product to requirements during processing, storage, handling, and distribution.
ISO 13485:2016 Clause 7.5.1. Production and service provision not adequate Production and service provision was not adequately planned, carried out, monitored, and controlled to ensure that product conforms to specification.
ISO 13485:2016 Clause 8.3.1. Nonconforming product not adequately evaluated Nonconforming product was not evaluated to determine the need for an investigation and notification of any external party responsible for the nonconformity.
ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for 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 have not been documented.
ISO 13485:2016 Clause 6.4.2. Arrangements for control of contaminated product not planned and documented Arrangements were not adequately planned and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of the work environment, personnel, or product.
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 serve as potential input into risk management for monitoring and maintaining product requirements as well as the product realization or improvement processes.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.70(g)(1). Maintenance schedule, Lack of or inadequate schedule Schedules for the adjustment, cleaning, and other maintenance of equipment have not been adequately established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions 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 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.75(b). Lack/Inad procedure-Monitoring/Control of Validated Proces Procedures for monitoring and control of process parameters for a validated process have not been established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
21 CFR 820.75(a). Documentation Process validation have not been adequately documented and adequately approved.
21 CFR 820.75(c). Documentation - review in response to changes or deviations There is no documentation of the revalidation of a process performed in response to changes or process deviations.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
21 CFR 820.100(a)(3). Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.
21 CFR 820.90(a). Nonconforming product evaluation/investigation The evaluation of nonconforming product has not been documented.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Appropriate procedures have not been defined and followed for controlling environmental conditions.
21 CFR 820.75(a). Lack of or inadequate process validation A process whose results cannot be fully verified by subsequent inspection and test has not been adequately and fully validated and approved according to established procedures.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures have not been defined and followed to prevent contamination of equipment or product by certain substances.
21 CFR 820.100(a)(1). Procedure for analysis of data sources The corrective and preventive procedures addressing the analysis of sources of quality data to identify existing and potential causes of nonconforming product or other quality problems were not complete.
21 CFR 820.75(c). Documentation - review in response to changes or deviations There is no documentation of the revalidation of a process conducted in response to changes or process deviations.
21 CFR 820.150(a). Storage procedures to avoid release of unsuitable product Procedures for controlling the storage of product in storage areas and stock rooms are not adequate to ensure that no obsolete, rejected, or deteriorated product is distributed.
Official Action Indicated (OAI)
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. 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
North Brunswick, New Jersey, United States. Part of