Baxter Healthcare Receives Especially Nasty Warning Letter

Baxter Healthcare Receives Especially Nasty Warning Letter

June 11th, 2013 // 5:48 pm @

Latest FDA and cGMP Compliance News

FDA is continuing a rather aggressive crackdown on cGMP violations, and we are seeing a lot of tough warning letters being issued. But every month or two, we notice a warning letter that is particularly unpleasant, given the types of cGMP violations that are noted therein. The latest sample is a warning letter for Baxter Healthcare, who is now a repeat cGMP offender at several plants.

For instance, a Baxter plant in NC had several environmental flaws. There was a problem with sanitizing and sterilizing equipment, and FDA also noted that some filters and screens used in a product fill line had many discolored areas, chipped paint, coalescing drops and clumps of dark material that FDA determined was mold.

Baxter did stop product shipments made on the line after the November 2012 483, but FDA stated that Baxter did not figure out how long the problems had been there. It also did not determine how the mold had grown to a TNTC, or too numerous to count level at the fill line.

Also, Baxter had several 483 violations that were found in an earlier audit. Many of you probably know – if you have repeat 483 observations, these are viewed very seriously by the agency, and normally a warning letter is issued. Some of the repeats included not investigating and remediating mold that was found in filters going back to July 2010. Baxter did not establish proper laboratory controls, as well.

FDA’s warning letter then took a serious turn, stating that Baxter had downplayed safety and quality effects that the mold caused, which were found on the ‘clean’ side of several HEPA filters that supplied air to sterile filling regions. Baxter said that the products that were made in these areas were completely and terminally sterilized so it was not a problem. But FDA cautioned that sterile products need to also be protected from all microbiological contamination during all processing, even if they are terminally sterilized.

Also, there was a problem with bags that are used for injectable products at a Puerto Rico plant that caused a partial recall of 24 lots. Baxter did  not recall the rest because it thought there was a very low risk of patient harm. Baxter only did the recall after FDA noted the issue, and after the firm got 30 complaints about the defects in about 3 out of 10 bags.

The same plant also did not file Field Alert Reports. These are required by FDA to be filed when a firm is made aware of an issue that can cause problems with product safety. The plant did not do this. The agency also noted that the identical violation was noted in an earlier inspection in 2011.

FDA then said that another inspection at another plant found several problems with corrections and interventions that centered on the sanitation of a sterile facility.

This warning letter is a good indicator that FDA is cracking down on drug companies with systemic problems that affect many plants.


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