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FDA establishment 3012639937, Bellingham, Washington, 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: Jul 24, 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 7.3.7: Design and development validation not performed as planned1
ISO 13485:2016 Clause 7.3.7. Design and development validation not performed as planned Design and development validation was not adequately performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
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.
ISO 13485:2016 Clause 7.3.10. Design and development files not maintained A design and development file was not maintained for each medical device type or medical device family.
ISO 13485:2016 Clause 4.1.5. External party controls do not include written quality agreements Control over outsourced processes that affect product conformity to requirements do not include written quality agreements.
ISO 13485:2016 Clause 6.3. Maintenance records not maintained Maintenance records have not been adequately maintained.
ISO 13485:2016 Clause 7.5.8. No documented system to assign unique device identification (UDI) A system to assign unique device identification (UDI) to the medical device was not documented.
7382.850, Inspection of Medical Device Manufacturers
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
Bellingham, Washington, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.