West-Ward Investigations Into Metal Contamination Don’t Measure Up

September 6, 2013

West-Ward Pharmaceuticals has received a Form 483 for lax investigations into metal contaminants and batch deficiencies following an inspection of its Eatontown, N.J., plant.

Investigators found that West-Ward failed to identify all potential sources of metal contamination for lots of lisinopril and hydrochlorothiazide 20 mg/25 mg tablets, carisoprodol 350 mg, prednisone, USP 10 mg tablets and lisinopril 40 mg tablets.

The FDA was particularly dismayed because, “although all of these lots were recalled, the firm plans to resume manufacturing operations of these products.”

West-Ward also did not conduct investigations into the confirmed presence of metal contamination in metal detector rejects, the form reads.

Investigators found that three lots of isosorbide mononitrate 30 mg tablets and one lot of 60 mg tablets were rejected for “sticking and/or illegible logos attributed to the design of the tooling that caused air pockets between the tooling and the tablets during compression,” the form reads.

While the lots, manufactured between September and October 2012, were rejected, the investigation didn’t extend to other lots of the same drug that also had illegible logos and are currently on the market, the FDA said.

Don’t give the FDA anything to complain about when they pay your facility a visit. Let the Eighth Annual FDA Inspections Summit teach you the rules of inspections and standards. Register today.