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OTC drugmaker Emilia Resources drew a Form 483 from the FDA for failing to validate manufacturing processes and establish data controls, among other lapses at its facility in De Kalb, Mississippi. Read More
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