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FDA establishment 3033648890, Shelton, Connecticut, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Aug 12, 2026
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.
02018Inspections0
020192019Inspections0vs 2018+0
02020Inspections0vs 2019+0
020212021Inspections0vs 2020+0
02022Inspections0vs 2021+0
020232023Inspections0vs 2022+0
02024Inspections0vs 2023+0
020252025Inspections0vs 2024+0
12026Inspections1vs 2025+1
020272027 to dateInspections0
Most Cited at This Site
Inspections citing each reference
ISO 13485:2016 Clause 8.5.2: Corrective action procedures not documented1
ISO 13485:2016 Clause 7.4.1: Procedures for purchasing process not documented1
ISO 13485:2016 Clause 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for reviewing nonconformities, determining the causes of nonconformities, planning and documenting action needed and implementing such action, 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 and reviewing the effectiveness of corrective action taken have not been adequately documented.
ISO 13485:2016 Clause 7.4.1. Procedures for purchasing process not documented Procedures to ensure that purchased product conforms to specified purchasing information have not been documented.
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.
ISO 13485:2016 Clause 8.2.2. Complaint handling procedures lack required elements Procedures for timely complaint handling do not adequately include requirements and responsibilities for receiving and recording information, evaluating information to determine if the feedback constitutes a complaint, investigating complaints, determining the need to report the information to FDA, handling of complaint-related product and determining the need to initiate corrections or corrective actions.
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
Shelton, Connecticut, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.