A new guide has been published that is recommended reading for every manager in a medical device manufacturing company: How to Avoid and Respond to FDA Criticisms—Form 483 Letters—for Temperature, Humidity and Other Controlled Environments.
The number of FDA 483 letters are expected to increase this year, reflecting FDA's recent staff expansion and a narrowing of the recipient's response time to 15 days.
Quality managers of medical device manufacturing operations that receive the letters need to regroup quickly—and respond appropriately and quickly. Of course, a better strategy is to avoid receiving a public notice in the first place.
When you take a look at the public postings, it's clear to see that most of them were avoidable. Consider this notice that a medical device manufacturer recently received:
"Procedures for the control of manufacturing and storage areas where environmental conditions could be reasonably expected to have an adverse effect on product quality were not adequately followed [21 CFR 820.70(c)]. Relative humidity readings of 19% and 20%, which fall below your specified...limits, were disclosed in your failure investigations work area..."
Unfortunately, this is not a rare occurrence. There are a great number of GMP/GLP FDA-regulated organizations that thought they were in full compliance but neglected to document their environmental records. Quality managers often realize too late that the monitoring and reporting tools they use do not provide evidence of gap-free records or in-spec data between required calibration intervals. For example, many of them don't factor in the impact on their chart recorders or data loggers when there is a power outage or network interruption. These are exactly the triggers for negative FDA actions or product loss.
Device manufacturers can find valuable guidance in How to Avoid and Respond to FDA Criticisms—Form 483 Letters—for Temperature, Humidity and Other Controlled Environments. The concise 10-step guide can be downloaded from Veriteq's Web site.
Ken Appel is vice president of regulated markets for Veriteq, which provides environmental monitoring of temperature, humidity, and other critical variables in controlled environments for medical device manufacturers and other FDA-regulated industries where product loss or audit failures are unacceptable. He can be reached via e-mail at firstname.lastname@example.org or by phone, 604/273-6850.