Devices

QS Violations Seen in Lymol Medical Inspection

A 2/3-2/12 FDA inspection at Lymol Medical, Woburn, MA, found Quality System Regulation violations in the firm’s manufacturing of Elite X Class rigid bronchoscope systems and Premier S Class silicone stents. A just-released 4/7 Warning Letter says specific violations were:

failing to validate according to established procedures a process whose results cannot be fully verified by subsequent inspection and tests;
failing to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation;
failing to establish and maintain documented procedures for acceptance activities including inspections, tests, or other verification activities to verify that the specified requirements for the product are met;
failing to evaluate complaints to determine whether the complaint represents an event that is required to be reported to FDA under the Medical Device Reporting regulation;
failing to evaluate and investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
failing to establish and maintain purchasing documents (includes an agreement) that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received products and services;
failing to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications; and
failing to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured following the device master record, including the dates of manufacture, the quantity manufactured, the quantity released for distribution, acceptance records, primary identification label and labeling used for each production unit, and any unique device identifier or universal product code and any other device identification(s) and control number(s) used.

Lymol was told to take prompt action to correct the violations addressed in the letter and was told to respond with a list of specific steps it has taken to correct the violations and prevent a recurrence of the same or similar violations, with documentation of each step and a timetable for implementation of the steps.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome