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# Data Integrity a Top Concern for FDA in 2016: Analysis
- URL: https://www.fdaweb.com/data-integrity-a-top-concern-for-fda-in-2016-analysis/
- Published: 2017-01-09T12:00:00.000Z
- Updated: 2026-09-14T21:58:47.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5137662

Data integrity was a top concern for FDA In 2016, according to an [analysis](https://www.healthlawpolicymatters.com/2017/01/04/health-care-enforcement-review-2017-outlook-fdas-wide-ranging-activities/?utm%5Fsource=Mintz+Levin+-+Health+Law+%26+Policy+Matters&utm%5Fcampaign=187bc0cae2-RSS%5FEMAIL%5FCAMPAIGN&utm%5Fmedium=email&utm%5Fterm=0%5F85e0fa) by the law firm Mintz Levin. “FDA focused on technical compliance issues that can pose risks to the safety of regulated products, such as data integrity within drug and device manufacturing facilities and unsanitary conditions in compounding pharmacies,” the analysis says. “FDA issued 14 data integrity Warning Letters to drug companies, continuing a trend from 2013-2015, during which FDA issued 24 Warning Letters citing the same issue. This spike coincides with FDA’s release in April 2016 of the draft guidance [*Data Integrity and Compliance with cGMP*](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf?ref=fdaweb.com).”

The agency’s inspection observations showed a contrast between device manufacturers and drug manufacturers, the analysis says. “On the device side, the top three inspectional observations for 2016 were inadequate CAPA procedures (344 observations), inadequate complaint handling procedures (264 observations), and lack of written MDR procedures (146 observations),” it says. “The top three observations for drug companies were lack of quality control procedures (147 observations), lack of scientifically sound laboratory controls (133 observations), and failure to investigate discrepancies and failures (126 observations). The top observations for biologics firms and food establishments were failure to establish manufacturing SOPs (39 observations) and lack of effective pest exclusion measures (314 observations), respectively. The trend in recent years of FDA inspectors documenting deficiencies in procedural systems rather than focusing on specific product or systems deficiencies certainly continues.”

The analysis also finds that the number of significant settlements involving alleged violations of the Food Drug & Cosmetic Act continue to increase, “and in some cases those settlements were made with downstream players in an increasingly complex global supply chain for regulated products. Most recently, on December 7th, the [government announced](http://www.fda.gov/iceci/criminalinvestigations/ucm533077.htm?ref=fdaweb.com) that it had entered into a “wide-ranging agreement” with GNC Holdings Inc., the largest retailer of dietary supplement products, “to reform its practices related to potentially unlawful dietary ingredients and dietary supplements, and … to embark on a series of voluntary initiatives designed to improve the quality and purity of dietary supplements.” And this past November, the government [settled a civil and criminal case](http://www.fda.gov/ICECI/CriminalInvestigations/ucm528460.htm?ref=fdaweb.com) involving medical device manufacturer Biocompatibles Inc., which pleaded guilty to misbranding its embolic device used to treat liver cancer, LC Bead, and to allegations under the False Claims Act that the company caused false claims to be submitted to government health care programs for unapproved uses.

  
Lastly, the law firm says it appears that FDA is delaying any significant changes to its off-label communications policies. It notes that the agency recently announced an extension of the comment period through April, delaying any policy announcement until at least late this year.