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Vipor Chemicals drew a warning letter from the FDA for CGMP violations observed during an inspection last year at its facility in Vadodara, Gujarat — including the use of an API supplied by a manufacturer on an FDA import alert. Read More
The FDA cited OTC and prescription drugmaker Woodfield Pharmaceutical of Houston, Texas for non-compliant batch reviews, complaint handling and quality control at its facility. Read More
Employees were seen touching equipment or other surfaces outside of the ISO 5 area with gloved hands and then conducting aseptic processing in the cleanroom. Read More
The FDA hit Hangzhou SunKing Nonwovens with a warning letter, citing the manufacturer for numerous quality violations at its Hangzhou, Zhejiang facility. Read More