Vitalograph Spirometers & Peak Flow Meters

Vitalograph Ltd., 6-Aug-99, Spirometers and peak flow meters

4. Failure to establish and maintain process control procedures for the monitoring and control of process parameters during production, as required by 21 CFR 820.70(a) and (b). For example, the firm failed to measure the temperature of the wave-soldering machine at the start of every PCB Kit as stated in the soldering machine SOP.

5. Failure to ensure all equipment used in the manufacturing process meets specified requirements, as required by 21 CFR 820.70(g). For example, the firm failed to set the machine control settings for the soldering machine at 6.5 as required by their written procedure. The speed was set at 6.

6. Failure to maintain schedules for- maintenance of equipment to ensure that manufacturing specifications are met, as required by 21 CFR 820.70(g)(1). For
example, there is no schedule for changing the solder bath nor has the firm completed an assay to check the solder for contamination to know what an appropriate schedule should be. In addition, specific gravity of the flux sprayed on the PCBs has not been checked.

7. Failure to ensure adherence to applicable equipment maintenance schedules, as required by 21 CFR 820.70(g)(2). For example, monthly and quarterly wavesoldering machine maintenance was not documented for 1998 and 1999 nor could the firm locate maintenance records for 1995, 1996, or 1997.

8. Failure to validate and document a manufacturing process, as required by 21 CFR 820.75(a). For example, although your firm stated that they validated the ATE PCB test equipment, there was no documentation to substantiate that it was performed.

9. Failure to adequately validate software for its intended use according to established protocol and to document activities and results, as required by 21 CFR 820.70(I). For example, the software was not adequately validated for its intended use nor documented appropriately.

Your firm’s response is that all validation procedures will be written for the software processes listed above. You did not provide documentation. This response is inadequate.

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.

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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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