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.
Last Week: Illinois
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:
- HomeChoice Automated Peritoneal Dialysis (APD) Systems
- HomeChoice Pro Automated Peritoneal Dialysis (APD) Systems
- IPUMP syringe-style intravenous, epidural or subcutaneous delivery infusion pump
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:
- Baxter's alleged failure to "adequately establish procedures for corrective and preventive actions"
- failure to establish and maintain corrective and preventive action procedures that include requirements for ensuring the corrective and preventive action is effective
- failure to adequately establish procedures to ensure equipment is routinely calibrated, inspected, checked and maintained
- All observations had previously been made in 2012, FDA said.
Two additional observations noted failure to adequately establish design validation procedures or valid statistical techniques to verify product capabilities and characteristics.
Other Warning Letters Since 2013
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.
Newest Warning letter
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:
- In one case, "mathematical errors that resulted in insufficient sample units pulled for functional testing"
- Nonconformance records (NCR) that were not opened quickly enough and lacked a standard operating procedure for cancelling NCRs
- Device history records were inadequate, lacked a complete record of all changes made, and in other cases noted that lots that contained defects were accepted anyway.
- Validation testing was not conducted in cases where it should have been
- Suppliers were not evaluated according to an established corporate quality procedure despite some certificates of analysis (COAs) containing "similar test values" across different batches, indicating that falsification may have taken place.
- Routine maintenance, including calibration, of equipment was not performed according to schedule in several cases
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 BaxterAll Warning Letters to Baxter