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The FDA found serious violations at Sun Pharma’s Halol, Gujarat facility in an inspection earlier this month, hitting the company with a Form 483 for issues ranging from data integrity to employee training. Read More
The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Read More
The FDA hit RAM Pharma, a drug compounding and outsourcing firm, for numerous failures at its Idaho Falls facility, including repeat findings of microbial growth and lax air sampling. Read More