Detroit-based drug manufacturer Vertellus received a Form 483 with seven observations from an FDA inspection of its Zeeland, Mich. facility. The Mar. 25-April 9 inspection revealed problems across the facility’s quality, materials and laboratory systems.
The agency said the firm failed to properly investigate a returned shipment of mislabeled Cetylpyridinium Chloride Monohydrate USP. The facility reprocessed the mislabeled lot without determining the cause of the discrepancy.
The agency also hit the firm for incomplete cleaning and maintenance logs as well as storing in-process API intermediaries without proper tagging.