The latest Form 483 that Aurobindo has received from the US Food and Drug Administration (FDA) concerns its Medchal, India, finished dosage manufacturing facility.
Within the inspection report, the agency highlighted 10 observations of concern regarding the plant and concluded that the “Quality Unit has not performed the necessary assessments/reviews to ensure that the objectionable conditions do not negatively affect the manufacturing process.”
The observations include finding ‘uncontrolled, loose handwritten notebooks’ containing laboratory test data results.
In addition, the FDA’s inspector documented piping connected to an air conditioner unit that was distributing condensed water to a bucket on the plant floor. This process was completed without documentation or procedure.
An area of particular concern for the agency was the finding that Correction Action/Preventative Action (CAPA’s), begun in response to complaints, were “not always sound or comprehensive to address all potential root causes,” with affected products destined for the US market.
The heavily redacted section of the report does not make clear what the entirety of the issues are but does openly reference missing pamphlets in packaging and that corrective action taken had not addressed “similar complaints with [a] similar root cause.”
For Aurobindo, this latest Form 483 is third that the FDA has made public during 2019.
In April, Aurobindo’s Telangana plant received 11 observations, again suggesting that the company’s Quality Unit had not performed necessary action to maintain aseptic manufacturing conditions.
In February, a different facility at the same location was revealed to have received two observations relating to inadequately established and followed contamination procedures.
Aurobindo’s share price is down by 12.5% since the start of the year.
