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The FDA hit German bulk drug substance manufacturer Dynavax GmbH with a Form 483 over seven violations seen at its Düsseldorf facility, including inadequate corrective and preventive actions (CAPAs). Read More
The agency noted that the product’s labeling lists its active ingredient as diphenhydramine hydrochloride, but the NDC listing says the active ingredient is bromodiphenhydramine hydrochloride. Read More
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