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FDA establishment 2523891, Branchburg, New Jersey, United States. Part of Next Medical Products Company's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 1
Last inspection ended: Dec 10, 2025
Warning letters: 1
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.
21 CFR 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
Official Action Indicated (OAI)
Jun 21, 2024
Devices · Compliance: Devices
5 cited references
21 CFR 820.75(a). Documentation Process validation activities have not been adequately documented.
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(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 820.75(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 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated and maintained have not been adequately established.
Voluntary Action Indicated (VAI)
Apr 7, 2023
Devices · Compliance: Devices
4 cited references
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 820.75(a). Documentation Process validation activities have not been adequately documented.
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 820.30(f). Design verification - documentation The design verification results, including method(s), the date and the individual(s) performing the verification, were not adequately documented in the design history file.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.250(a). Statistical techniques - Lack of or inadequate procedures Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been adequately established.
21 CFR 803.17(a)(3). Lack of System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
21 CFR 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a specification, method and process have not been established.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
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 820.72(b). Remedial action When test/measurement equipment was found to not meet accuracy and precision limits, inadequate action was taken to evaluate whether there was any adverse effect on the device's quality.
21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
21 CFR 820.50(a)(1). Evaluation and Selection, Suppliers, Contractors, etc. Potential suppliers were not evaluated and selected based on their ability to meet specified requirements.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities 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 820.184. DHR - not or inadequately maintained A device history record has not been adequately maintained.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established.
21 CFR 803.17(a)(3). Lack of System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
21 CFR 820.250(b). Sampling methods - Lack of or inadequate procedures Procedures to ensure sampling methods are adequate for their intended use have not been established.
Voluntary Action Indicated (VAI)
Mar 12, 2013
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
Aug 10, 2010
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
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
Branchburg, New Jersey, United States. Part of