FDA Cites Pfizer for Procedures at Indiana Plant

The Food and Drug Administration told Pfizer ( PFE) it has quality-control concerns about an Indiana plant where the company makes prescription drugs.

Pfizer manufactures antibiotics including Cefobid, Permapen and Unasyn at the plant in Terre Haute. It has no pending applications on any new drugs that it intends to make there.

The company said it expects to finish renovating the plant in the next six months and sees no impact on new-product filings.

In its letter, the FDA said Pfizer failed to assure that procedures at the plant were adequate to prevent bacterial contamination of medicines. The letter specified 31 separate problems, although Pfizer said in a subsequent release that it had corrected 11 items while the inspection was in progress.

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