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The FDA issued a warning letter to AllerQuest for design flaws at its Plainville, Connecticut sterile drug manufacturing plant, including gaps in doors leading to sterile areas. Read More
The FDA hit Strides Pharma Science with a warning letter for discarding records and other serious violations at the generic drugmaker’s facility in Puducherry, India. Read More
The FDA hit API and repackaging facility Giles Chemical of Waynesville, N.C., with a lengthy Form 483 for multiple violations including the use of “reclaimed water” in manufacturing API products. Read More
The FDA issued a warning to a Belleville, N.J. OTC drugmaker US Pharmaceuticals for serious failures in its purified water system including high microbial counts. Read More
The FDA hit Illinois-based generic drugmaker Akorn with an extensive warning letter for violations at its Somerset, New Jersey facility — the company’s second warning of the year. Read More