Baxter warned by FDA over repeat failings at two plants
pharmafile | June 14, 2013 | News story | Manufacturing and Production |Â Â FDA, baxterÂ
Baxter has attracted the ire of the US Food and Drug Administration over quality failures at two sterile product manufacturing facilities.
The regulator sent Baxter a warning letter at the end of last month saying facilities in Marion, North Carolina, and Jayuya in Puerto Rico, had both failed inspections and the company had failed to put right deficiencies found on previous visits by the FDA.
It also notes that a third, unidentified sterile product facility in Baxter’s network has also had Good Manufacturing Practice (GMP) deviations requiring the issuance of a Form 483.
The letter says Baxter allowed conditions at its Marion facility to become unsanitary by failing to clean and maintain equipment, for example encouraging mould to grow in close proximity to the plant’s large volume parenteral (LVP) filling line.
Evidence of the lapses in quality included discoloured HEPA filters used to ensure the air in sterile filling areas was uncontaminated, chipping paint and “clumps of dark material that FDA testing later revealed was mould”.
Baxter did not operate a sound environmental monitoring process, and the company’s argument that a terminal sterilisation process before release of product was sufficient to tackle the contamination issues, was rejected by the regulator.
As with many recent FDA warnings the letter also notes that Baxter failed to investigate batch failures, even in some cases to check whether a failed batch had been distributed. The problems were first uncovered “at least as far back as July 6, 2010”, according to the agency, which also takes issue with a lack of scientifically sound laboratory testing protocols to ensure drug quality.
Turning to Puerto Rico, the FDA notes occasions where quality failures such as leaking bags led to product being discarded, but Baxter took no action to “mitigate risks posed by affected product” that had already been shipped out.
Deciding that blue caps on the affected bags would minimise the risk of contamination, Baxter took no subsequent action. However, the FDA said its inspection uncovered dozens of complaints of badly fitting caps that would likely have impacted the sterility and stability of the contents.
Products made at the plant were also found to be contaminated with particulate material such as “paper fibre, cotton fibres, nylon fibres, PVC particles, cardboard, skin, polyester, polyethylene, human hair, rayon, and frangible material from the vial adapter”, according to the letter. Jayuya was also the subject of a warning letter sent by the FDA two years ago.
Contamination issues affected a Baxter plant in Castlebar, Ireland, in 2011, leading to a suspension in production of a number of peritoneal dialysis products made there. The company subsequently said the remediation work at the plant had cost around $30 million to resolve.
Phil Taylor
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