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FDA establishment 3016774562, Boston, Massachusetts, United States. Part of Whele LLC (Perch)'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Jul 18, 2023
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.
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.
21 CFR 820.90(a). Nonconforming product control Products that do not conform to specifications are not adequately controlled.
21 CFR 803.40(a). Report of death, injury The importer failed to submit a report to FDA, with a copy to the manufacturer, within 30 days after receiving information that one of its marketed devices may have caused or contributed to a serious injury.
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 820.25(b). Training records Personnel training is not documented.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately established and maintained.
21 CFR 820.250(b). Sampling plans Sampling plans are not based on valid statistical rationale.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained and implemented.
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
Boston, Massachusetts, United States. Part of