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Quality shortcomings including rusty equipment and data integrity lapses drew a warning letter from the FDA for GPT Pharmaceuticals’ facility in Hyderabad. Read More
The FDA issued a warning letter to LNK International for failing to fully investigate contaminated lots of antihistamines it released to the market. Read More
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