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The FDA issued warnings to the following facilities in Australia, Korea, the European Union and the United States for deficiencies in records, documentation, GMPs, testing and validation: Read More
A heavily staffed FDA inspection of pharmaceutical giant Mylan’s manufacturing facility in Morgantown, West Virginia netted the company a lengthy Form 483 listing numerous deficiencies in the firm’s quality control unit. Read More
Chinese API manufacturer Henan Lihua drew a warning from the FDA over serious testing violations, inaccurate records and drug quality failures at its facility in Anyang, Henan. Read More
The FDA hit Biologique Recherche with a warning letter after observing multiple violations at its Paris facility, noting inadequate testing methods, quality control concerns and a lack of validation for manufacturing processes, among other issues. Read More
The firm also failed to control its computer systems to assure that changes in master production and control records could only be done by authorized staff. Read More
The FDA hit Surmasis Pharmaceutical of Des Moines, Iowa with a Form 483 after a February inspection revealed problems with laboratory records, computer systems and equipment inspections. Read More
Sponsors may be referred to the Office of New Drugs if the product is a biological product or if it is not eligible for submission or approval as an ANDA but may be suited for another pathway. Read More
Chinese API manufacturer Henan Lihua drew a warning from the FDA over serious testing violations, inaccurate records and drug quality failures at its facility in Anyang, Henan. Read More
The manufacturer relied on certificates of analysis from unqualified suppliers instead of testing the attributes of incoming raw materials used in manufacturing. Read More
The FDA hit Biologique Recherche with a warning letter after observing multiple violations at its Paris facility, noting inadequate testing methods, quality control concerns and a lack of validation for manufacturing processes, among other issues. Read More