The warning letter followed an inspection by the US Food and Drug Administration (FDA) at Baxter’s North Cove facility in Marion, North Carolina and noted specifically that Baxter had not corrected previous manufacturing violations at the site, specifically failing to:
- clean, maintain, and sanitize and/or sterilize equipment and utensils at appropriate intervals
- thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications
- establish laboratory controls to assure that components, drug product containers, closures, in-process materials, labelling, and drug products conform to appropriate standards
However, Baxter spokesperson John O’Malley told in-Pharmatechnologist.com that “at this time, there are no restrictions on the manufacture, shipment or customer ordering of products made at these facilities as a result of this warning letter.”
The facility manufactures IV solutions and peritoneal dialysis solutions, as well as containers and component parts for other Baxter facilities.
Two of the violations were repeat observations from an inspection in August last year and O’Malley said Baxter was in continuous dialogue with the FDA in order to resolve the outstanding issues.
“Many corrective actions to issues raised in this letter have been implemented by Baxter as part of its continuous improvement efforts.”
The warning letter from last August’s inspection identified “clumps of dark material” later identified as mould on numerous HEPA filters on a Fill line at the facility. This latest letter states its concerns that the root cause that allowed the mould to proliferate to a level too numerous to count has still not been identified by Baxter.
Puerto Rican Problems
The letter also cited violation issues at Baxter’s Jayuya facility in Puerto Rico - which manufactures large and small volume IV solutions, IV drug reconstitution systems and parenteral nutrition products - inspected between March and April this year.
Not the first warning for the plant, the FDA pulled Baxter up on repeat observations from a warning received in January 2011, including failing to completely investigate several unexplained discrepancies. The letter cited a bag leak detected during routine microbiology testing and particulate matter found in drug product solution during manufacturing as examples.
The plant was also pulled up on a post marketing report violation, failing to submit NDA Field Alert Reports (FARs) within three working days of receipt of information concerning a product defect.
Baxter has three manufacturing facilities on the island employing around 4,000 people. Recently the company unveiled it was investing $35m in its Aibonito plant, transforming the plant’s focus and lowering capacity by transferring some production to the Dominican Republic.
When asked if Baxter had any plans to do a similar thing at Jayuya following repeated manufacturing violations, O’Malley replied in the negative, adding the company has actually “made significant investments in Jayuya over the last several years to expand capacity.”
Furthermore, he continued, “the investments the company has made, and continues to make, is evidence of a commitment to maintaining a significant presence in Puerto Rico.”