Med-Mart Pulmonary Services

Company: Med-Mart Pulmonary Services
Product: Inhalation solutions
Date: 9/30/02

Failure to perform routine calibration and to assure proper performance of all automatic, mechanical, and electronic equipment used in the manufacture, processing, packing, and holding of a drug product [21 CFR 211.68]. For example, your filtration unit, _____ small batch filler unit, industrial scale, _____ Pump, and the _____ Machine used to fill, label, and seal drug products have not been calibrated or otherwise checked to ensure they perform their operations consistently and accurately.

FDA District: San Francisco District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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