FDA again slams Biocon's troubled plant in Malaysia, citing 8 manufacturing shortfalls

Biocon’s troubled Malaysia manufacturing facility has been slammed once again by the FDA. After a recent inspection, the regulator cited the plant for eight observations.

The latest citation follows an FDA visit to the site from July 10 to July 20. Afterward, the FDA wrote up its findings in a Form 483 filing that highlights inadequate corrective and “repeat” problems that it observed on previous visits.

In a letter posted on the FDA’s website, Biocon was cited for a number of ongoing issues such as scissors stored in non-sterile holders being used to open “bags of sterile components," improper blockage of air filters, insufficient cleaning of sterile machinery and numerous problems with batch testing and record-keeping.

The filing, which contained numerous redactions, also cited Biocon’s failure to lay out detailed, written guidelines for some manufacturing operations.

“Specifically, your firm has no written procedures on what corrective actions are to be performed when aseptic areas have a loss in differential pressure to return to a state of cleanliness that is suitable for resumption of aseptic operations,” the FDA said.

Biocon was also reprimanded for a lack of employee training.

But the facility in Johor is no stranger to the FDA’s ire.

Last August, an FDA inspection at the plant resulted in six observations that put a cloud on the company’s efforts to produce it and Viatris’ Semglee, an insulin biosimilar that snared a prized interchangeability tag earlier in the year.

Previously, the company was hit by FDA complete response letters in August 2019 and February 2020.