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FDA establishment 3005182235, Brookpark, Ohio, United States. Part of Compass Health Brands's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 3
Official action indicated: 0
Last inspection ended: Feb 27, 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
12022Inspections1vs 2021+1
020232023Inspections0vs 2022−1
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 7.4.3: Purchased product verification activities not established or implemented1
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 adequately established and implemented.
Voluntary Action Indicated (VAI)
Nov 17, 2021
Devices · Compliance: Devices
7 cited references
21 CFR 820.120(a). Remain legible Labels were not printed, applied and affixed so as to remain legible and affixed during processing, storage, handling, distribution, and/or use.
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.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been adequately established.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
21 CFR 820.120(b). Labeling inspection - UDI Labeling was not sufficiently examined by a designated individual for accuracy including unique device identifier (UDI) or universal product code (UPC).
21 CFR 820.130. Packaging Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been 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 803.50(a)(1). Report of Death or Serious Injury An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
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
Brookpark, Ohio, United States. Part of