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FDA establishment 3002616700, Middletown, Connecticut, United States. Part of Microspecialties's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 4
Official action indicated: 2
Last inspection ended: Feb 18, 2025
Warning letters: 2
Recalls since 2016: 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 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.80(d). Lack of or inadequate final acceptance procedures Procedures for finished device acceptance have not been adequately established.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 820.100(b). Documentation Corrective and preventive action activities and/or results have not been adequately documented.
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.
Official Action Indicated (OAI)
Sep 4, 2014
Devices · Postmarket Assurance: Devices
3 cited references
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 820.70(c). Environmental control Lack of or inadequate procedures Procedures to control environmental conditions have not been adequately established.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
21 CFR 820.75(b)(2). Documentation of validated process performance There is no documentation of monitoring and control methods and data for a validated process.
21 CFR 820.75(a). Documentation Process validation activities have not been documented.
21 CFR 820.75(c). Documentation - review in response to changes or deviations There is no documentation of the review and evaluation of a process performed in response to changes or process deviations.
Voluntary Action Indicated (VAI)
May 10, 2011
Devices · Compliance: Devices
7 cited references
21 CFR 820.75(a). Documentation Process validation activities and results have not been documented and adequately approved.
21 CFR 820.75(c). Documentation - review in response to changes or deviations There is no documentation of the review and evaluation of a process and revalidation of a process performed in response to changes or process deviations.
21 CFR 820.22. Quality Audits - defined intervals Quality audits were not performed at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures.
21 CFR 820.40. Lack of procedures, or not maintained Document control procedures have not been maintained.
21 CFR 820.70(a). Production processes Production processes were not conducted to ensure that a device conforms to its specifications.
21 CFR 820.80(c). Lack of or inadequate In-process acceptance procedures Procedures for the acceptance and control of in-process product 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.
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
Middletown, Connecticut, United States. Part of