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The FDA issued Dr. Reddy’s a Form 483 after an inspection of its Medak, Telengana facility in India determined it did not establish quality agreements with material suppliers and failed to complete multiple CAPAs in a timely manner, among other violations. Read More
An FDA inspection of drugmaker Goran Pharma in November netted the company a Form 483 with 17 observations ranging from inadequate employee training to laboratory deficiencies and contamination risks. Read More
The FDA hit Kolmar Korea with a Form 483 over numerous violations — including negligent handling of documents, lack of employee training and failure to conduct process validation — after a September inspection of its Sejong City, South Korea facility. Read More
In its first required inspection metrics report for 2017, FDA officials found a median time of 102 days between inspection requests by the FDA to a facility and the beginning of inspections, and a median of seven days between the beginning of a pre-approval inspection and the issuance of a Form 483. Read More
The FDA issued a Form 483 to Plainville, Connecticut drugmaker AllerQuest for sterility issues and air control deficiencies after an inspection spanning from August to September. Read More
The FDA warned Clover Custom Blending after an investigation of its Tampa, Florida-based manufacturing plant revealed uninvestigated out-of-specification results, missing written procedures and other deficiencies. Read More