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FDA establishment 3001451466, Branford, Connecticut, United States. Part of Madison Polymeric Engineering's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 1
Last inspection ended: Feb 22, 2019
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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(a). Production processes Production processes were not controlled and monitored to ensure that a device conforms to its specifications.
21 CFR 820.25(a). Personnel Personnel do not have the necessary training and experience to perform their jobs.
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 established.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been established.
21 CFR 820.70(g). Equipment design and installation Equipment used in the manufacturing process has not been appropriately designed , constructed , placed and installed to facilitate maintenance, adjustment, cleaning, and use.
21 CFR 820.80(a). Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities 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 validated according to established procedures.
Voluntary Action Indicated (VAI)
Mar 23, 2015
Devices · Compliance: Devices
3 cited references
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 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)(5). Changes to correct/prevent quality problems Changes in methods and procedures needed to correct and prevent identified quality problems are not implemented .
Official Action Indicated (OAI)
Jan 9, 2015
Devices · Postmarket Assurance: Devices
5 cited references
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
21 CFR 820.50(a)(1). Documented evaluation The evaluation of potential suppliers was not documented.
21 CFR 820.25(b). Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been adequately established.
No Action Indicated (NAI)
Oct 26, 2011
Devices · Compliance: Devices
4 cited references
21 CFR 820.50(a)(3). Acceptable supplier records, inadequate records Records of acceptable suppliers have not been adequately established.
21 CFR 820.25(b). Training records Personnel training is not documented.
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 established.
21 CFR 820.22. Quality audits - auditor independence Individuals who conduct quality audits have direct responsibility for the matters being audited.
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
Branford, Connecticut, United States. Part of