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Critical cleaning steps for equipment such as drug filtration equipment and bottling lines were not recorded in books employees used to log the dates and times of equipment cleaning. Read More
The FDA hit Korean drug supplier Barox with a warning letter for quality control, drug labeling and product storage issues at its Seongnam, Gyeonggi facility. Read More
For one product, the investigators were “unable to determine quantity of the lot due to the invoice having two different lots with unspecified units.” Read More
Contract drug manufacturer Jubilant HollisterStier drew a Form 483 after the FDA observed contamination risks at the firm’s Kirkland, Quebec facility. Read More
The facility failed to test incoming glycerin lots to verify identity and determine whether diethylene glycol or ethylene glycol was present, the agency said. Read More
The FDA has agreed to recognize drug and active pharmaceutical ingredient GMP inspections carried out by authorities in Belgium, Denmark, Finland, Latvia and Estonia, updating the 1998 mutual recognition agreement between the U.S. and the European Union. Read More
The FDA cited German drug manufacturer Pekana Naturheilmittel for cleaning violations and other problems observed at its Baden-Wurttemberg facility. Read More
The FDA cited OTC drug manufacturer Agropharma for violations at its Salinas, Puerto Rico facility, including inadequate conformance testing, batch records and quality control. Read More
Los Angeles, California OTC drugmaker Product Packaging West drew a warning letter from the FDA for current good manufacturing practice violations observed at its facility, including inadequate recordkeeping and component testing. Read More