A June 22 FDA warning letter to API manufacturer Chengdu KeCheng Fine Chemicals details an October 2022 conversation in which the firm’s general manager told the FDA that his company was not shipping products to the U.S. Read More

Twenty-five drugs manufactured by Intas Pharmaceuticals have been excluded from an FDA import alert because they are in short supply, the agency wrote in a June 2 import alert letter, banning, however, all other drugs manufactured at the company’s Sanand, India, facility. Read More

FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More

The best organizations use findings from both internal audits and third-party inspections to build knowledge for future improvement — using audit data to improve the audit program itself, says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More

Pharmedica USA’s Phoenix, Ariz., drug manufacturing facility was cited by the FDA in a warning letter for lack of a sterile environment for producing its OTC eye drops and for having a manufacturing facility that “was in a state of disrepair.” Read More

Multiple unaddressed violations of current good manufacturing practice, FDA regulations and noncompliance with a 2012 consent decree have earned India’s Sun Pharmaceutical a hefty list of corrective actions to complete before resuming drug exports to the U.S. Read More

Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of batches that ended up on the U.S. market and remained there without “adequate justification.” Read More

The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Read More

The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk drug substances. Read More

The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this and other issues raised in a recent inspection. Read More

Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Read More