Devices

Microspecialties Quality System Issues

A 1/14-2/18 FDA inspection at the Microspecialties facility in Middletown, CT, found Quality System Regulation violations in the firm’s work as a contract manufacturer of several Class 1 and 2 ophthalmic surgical devices. A 5/8 Warning Letter says the specific violations were:

failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria;
failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures; and
failure to ensure that sampling plans are written and based on a valid statistical rationale when used.

The letter says the firm’s responses to the inspection observations were either inadequate or their adequacy could not be determined. Microspecialties was told to promptly address the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with documentation for each action and a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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