While an inspection may seem like a distant concern, class II and class III manufacturers are technically subject to one at least every two years.

FDA’s regulations for quality systems––FDA 21 CFR part 820––have been on the books for years. As a result, the Agency expects all device manufacturers to fully understand and implement these regulations into their current quality systems.

In addition to the regulations themselves, FDA has laid out exactly how they intend to investigate device companies with the Guide to Inspections of Quality Systems, an older but still very useful guide to help you prepare for investigators.

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The FDA Group Ranks #3 on Boston Business Journal's "FAST50" List with 892.78% growth from 2012 to 2015.


WESTBOROUGH, MA, May 18, 2016 -- The Boston Business Journal recently ranked The FDA Group #3 on its list of 2016’s Fastest-Growing Private Companies in Massachusetts. In all, 76 companies were named to the list and the top 50 were designated as the “FAST50.” 

"These companies represent the best examples of the Boston economy's strength and vibrancy," said Carolyn M. Jones, the BBJ’s publisher and market president. "This kind of top-line growth is driving the state's economy and generating the kind of excitement that attracts global brands and their talent here."

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On April, 15th, the FDA issued a new draft guidance in response to rising concerns around data integrity at drug manufacturing sites both inside and outside the U.S. Data Integrity and Compliance with CGMP outlines the FDA’s initial recommendations for creating and managing data in accordance with the Current Good Manufacturing Practices (CGMP) laid out in 21 CFR Part 210, 211, and 212.

The new draft guidance answers a number of common questions concerning the “completeness, consistency and accuracy of data,” asserting that “[c]omplete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).” 

Much of the 13-page draft guidance goes on to explain how regulators expect companies to adhere to these new rules. To save you time during your review, we’ve summarized the eight key takeaways below:

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The FDA’s new draft guidance, Request for Quality Metrics, focuses on a new requirement that has many pharmaceuticals and device manufacturers scrambling to prepare: 

The collection and use of manufacturing quality metrics (MQM). Here’s the key line from the guidance explaining this new rule:

“In order to both inform FDA’s risk-based drug inspection scheduling and to better detect manufacturing conditions that may lead to a shortage, FDA intends to collect and use quantitative quality data to calculate certain quality metrics....

To help companies improve their understanding of processes and quality control, the FDA laid out four specific metrics that pharmaceutical manufacturers, medical device companies and others should pay particular attention to:

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More than half of all Form 483 observations and FDA warning letters cite problems with Corrective Action/Preventative Action plans, or CAPA.

Many of these deficiencies arise when internal investigations fail to find and resolve the root causes of these problems. Whether it’s cost, time, or lack of manpower on staff, it can be easy to settle for treating the symptoms of compliance issues rather than investing the resources needed to dig deeper.

Unfortunately, short term solutions only mean bigger problems down the road when unresolved quality issues return––usually causing more harm than they did before.

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