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FDA establishment 2027347, Phoenix, Arizona, United States. Part of Specialty Health Products's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 1
Last inspection ended: Dec 11, 2025
Warning letters: 1
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.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been adequately established.
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 820.22. Quality audits - Lack of or inadequate procedures Procedures for quality audits have not been adequately established.
21 CFR 801.20(a). Label to bear a unique device identifier The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet the requirements of 801 Subpart B and 21 CFR 830.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
21 CFR 820.184. DHR content The device history record does not demonstrate that the device was manufactured in accordance with the device master record.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
21 CFR 820.72(a). Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely calibrated have not been adequately established.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
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 adequately established.
21 CFR 820.200(a). Servicing - Lack of or inadequate procedures Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements have not been adequately established.
21 CFR 820.80(b). Lack of or inadequate receiving acceptance procedures Procedures for acceptance of incoming product have not been adequately established.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures 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 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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
Phoenix, Arizona, United States. Part of