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FDA establishment 3012238587, Warwick, Rhode Island, United States. Part of Criticare Technologies, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 5
Official action indicated: 4
Last inspection ended: Oct 28, 2025
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.70(a). Production processes Production processes were not developed to ensure that a device conforms to its specifications.
21 CFR 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
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 820.30(g). Design validation - Risk analysis Results of the design risk analysis were not adequately documented.
21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation 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 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been adequately established.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
21 CFR 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
21 CFR 830.300(a). Devices subject to device identification GUDID data submission requirements. The information required by the Global Unique Device Identification Database for each medical device version or model required to bear a unique device identifier (UDI) was not provided.
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(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
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(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.25(b). Training records Personnel training is not documented.
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 adequately established.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.30(a). Design control - no procedures Procedures for design control have not been established.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been established.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been established.
21 CFR 820.198(c). Investigation of device failures Complaints involving the possible failure of labeling and packaging to meet any of its specifications were not evaluated and investigated where necessary.
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 and 21 CFR 820.
21 CFR 820.140. Lack of or inadequate procedures for handling Procedures for product handling 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately 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 820.90(b)(1). Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been adequately established.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities have not been adequately established.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been established.
21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been adequately established.
21 CFR 820.70(i). Documentation of software validation Software validation activities and results for computers or automated data processing systems used as part of production 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 820.25(b). Training records Personnel training is not documented.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
21 CFR 820.60. Identification procedures, Lack of or inadequate procedures Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been adequately established.
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 820.90(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 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established.
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
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
Warwick, Rhode Island, United States. Part of