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FDA establishment 3005351361, Foxboro, Massachusetts, United States. Part of BL Healthcare, Inc.'s FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 820.40(a). Document review, approval by designated individual Documents were not reviewed and not approved by designated individual(s) prior to issuance .
21 CFR 820.80(d)(3). No release signature Finished devices were released for distribution without signature of the individual designated to authorize such release.
21 CFR 820.50(a)(2). Supplier oversight The type and extent of control to be exercised over suppliers was not clearly defined.
21 CFR 820.184(e). ID label, labeling The device history record does not include the primary identification label and labeling for each device.
21 CFR 820.20(c). Management review - defined interval, sufficient frequency Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency .
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 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.25(b). Training records Personnel training is not documented.
21 CFR 820.80(b). Incoming acceptance records, documentation Acceptance or rejection of incoming product was not documented.
21 CFR 820.80(c). Documentation In-process inspections, tests, or other verification activities and approvals were not documented.
21 CFR 820.40. Procedures not adequately established or maintained Document control procedures have not been adequately maintained.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
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
Foxboro, Massachusetts, United States. Part of