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FDA establishment 1218996, North Billerica, Massachusetts, United States. Part of Magellan Diagnostics's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 7
Official action indicated: 2
Last inspection ended: Aug 26, 2025
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 - Lack of or inadequate procedures Procedures for design verification have not been adequately established.
21 CFR 803.17(a)(1). Lack of System for Event Evaluations The written MDR Procedure does not include an internal system which provides for timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
21 CFR 806.10(a)(2). Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.
21 CFR 820.250(b). Sampling plans Sampling plans are not written and based on valid statistical rationale.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
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 adequately validated according to established procedures.
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 820.100(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.
Official Action Indicated (OAI)
Jun 22, 2021
Devices · Compliance: Devices
1 cited reference
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 adequately validated according to established procedures.
21 CFR 820.30(g). Design Validation - Risk analysis not performed/inadequate Risk analysis is inadequate.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
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 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 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 820.198(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 - 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 820.30(g). Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.
21 CFR 820.90(a). Nonconforming product, Lack of or inadequate procedures Procedures have not been established to control product that does not conform to specified requirements.
21 CFR 820.30(g). Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.
21 CFR 806.10(b). Time to report - 10 days A report of the required information regarding device correction and removal actions was not sent to FDA within 10 days of initiating the correction or removal.
21 CFR 820.30(i). Design changes - Lack of or Inadequate Procedures Procedures for design change have not been adequately established.
Official Action Indicated (OAI)
Jun 25, 2014
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
Feb 23, 2012
Devices · Compliance: Devices
1 cited reference
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
Voluntary Action Indicated (VAI)
Mar 9, 2011
Devices · Compliance: Devices
None posted
No Action Indicated (NAI)
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
North Billerica, Massachusetts, United States. Part of