Teva Criticized by FDA Over Inadequate Batch Investigations

Teva Pharmaceuticals USA left FDA investigators wanting more focus on batch investigations and cleaning procedures, prompting a Form 483 for the generic drugmaker.

During a recent investigation of Teva’s Sellersville, Pa., plant, agency investigators found issues with certain batch investigations.

Teva did not perform analytical testing of available reserve samples for five lots of drug products that were flagged for a lack of effectiveness, reads the six-observation form. The FDA also chided Teva for using a pump skid to make a batch of methylphenidate beads even though the skid was under quarantine after failing cleaning verification.

“Your deviation investigation … did not include corrective action after equipment was used while under quarantine status,” the form reads.

Teva was also cited for improper cleaning procedures. Drug residues were found on a “coffee grinder” used to grind up methylphenidate bead samples prior to moisture analysis. The problem is that the room and equipment underwent a major cleaning beforehand, the FDA said.

Teva said that it responded to the FDA’s concerns and the agency told the drugmaker the response was satisfactory.

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