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Posted 18 February 2014 | By Alexander Gaffney, RAC,
Medical device manufacturer Baxter has been hit with a rare one-two punch by the US Food and Drug Administration (FDA), which has sent the company two Warning Letters in as many weeks citing similar current good manufacturing practice (CGMP) issues.
As Focus reported last week, Baxter Healthcare was sent an extensive Warning Letter following a July and August 2013 inspection of the company's Round Lake, IL facility where it manufactures the following three devices:
All three are Class II (moderate risk) medical devices and, according to FDA, adulterated under the Federal Food, Drug and Cosmetic Act (FD&C Act) due to CGMP deficiencies found during its inspection.
The agency's letter to Baxter appeared to be especially serious in that it cited five instances in which current deficiencies had been noted in a previous Warning Letter to the company.
For example, the company was alleged to have improperly invested device failure reports by conducting less-than-thorough assessments. Some reports were "either incomplete or lacking of conclusions and corrective actions of the reviews," FDA wrote. Three other observations were also repeats:
Two additional observations noted failure to adequately establish design validation procedures or valid statistical techniques to verify product capabilities and characteristics.
The company also received a Warning Letter in June 2013 citing significant CGMP deficiencies at its Marion, NC manufacturing facility, where FDA inspectors said they found "multicolored coalescing droplets," and "clumps of dark material that FDA testing later revealed was mold." That letter also noted deficiencies found at the company's Jayuya, Puerto Rico facilities related to the (non) submission of Field Alert Reports (FARs).
Yet another letter, released in April 2013, cited the company for marketing an adulterated device that had not received proper approval from FDA.
Baxter's latest Warning Letter-its second in two weeks and fourth in the last year-refers to a lengthy inspection of its Irvine, CA facility conducted between December 2012 and June 2013. While there, FDA inspectors allegedly found more CGMP violations under 21 CFR 820, the quality system regulation (QSR).
As with the previous week's letter, this one notes many deficiencies related to Baxter's Corrective and Preventive Action (CAPA) program, which is intended to identify product deficiencies, determine how they happened and prevent them from occurring again. However, FDA noted at least eight major instances in which the company identified a CAPA case but failed to take appropriate action to remedy the cause of the problem.
The extensive letter notes a host of other alleged deficiencies, including:
The company was given 15 business days to respond from the date the letter was sent (19 December 2013). "Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice," FDA explained.
According to FDA records, the Warning Letter is Baxter's-including its subsidiaries-ninth since 2009.
WL to Baxter
Tags: warning letter
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