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FDA establishment 3029740697, Pleasant Hill, California, United States. Part of ZIIP, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Jan 12, 2026
Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 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 820.30(f). Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been maintained.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
21 CFR 820.100(a). Lack of or inadequate procedures Procedures for corrective and preventive action have not been adequately established.
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.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change 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 820.30(g). Design validation- Lack of or inadequate procedures Procedures for design validation have not been adequately established.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Pleasant Hill, California, United States. Part of