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FDA establishment 3030198312, Fairlawn, Ohio, United States. Part of Eclosion, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Aug 13, 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 7.4.1: Procedures for purchasing process not documented1
ISO 13485:2016 Clause 7.1: Processes needed for product realization not planned and developed1
ISO 13485:2016 Clause 7.4.3: Purchased product verification activities not established or implemented1
ISO 13485:2016 Clause 4.2.4: Lack of document control1
ISO 13485:2016 Clause 8.5.3: Preventive action procedures not documented1
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.
ISO 13485:2016 Clause 7.1. Processes needed for product realization not planned and developed Processes needed for product realization were not planned and developed.
ISO 13485:2016 Clause 7.4.3. Purchased product verification activities not established or implemented The inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements were not established and implemented.
ISO 13485:2016 Clause 4.2.4. Lack of document control Documents required by the quality management system have not been controlled.
ISO 13485:2016 Clause 8.5.3. Preventive action procedures not documented Preventive action procedures describing the requirements for determining potential nonconformities and their causes, evaluating the need for action to prevent occurrence of potential nonconformities, planning and documenting action needed and implementing such action, verifying that the 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 the preventive action taken 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 8.5.2. Corrective action procedures not documented Corrective action procedures defining the requirements for reviewing nonconformities, determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, 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 documented.
ISO 13485:2016 Clause 8.3.3. Records not maintained for nonconforming product actions detected after delivery Records were not maintained of actions taken to address nonconforming product detected after delivery or use.
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.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained and implemented.
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
Fairlawn, Ohio, United States. Part of