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A Pharmacia & Upjohn plant was slammed with its second FDA Form 483 in five years for failure to investigate discrepancies and out-of-specifications results, inadequate annual product reviews, failure to follow written procedures and inadequate documentation for cleaning procedures. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
Indian drugmakers are once again under scrutiny as the FDA issues warning letters and import alerts to India’s Pan Drugs Limited, Sipra Labs and Polydrug Laboratories. Read More
The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More
Drugmakers should notify the FDA and any affected trading partner within 24 hours of encountering suspected counterfeit products to prevent or limit them from entering or being distributed in the supply chain, the agency says in a notice published in the Federal Register. Read More
The FDA issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
Merck is recalling thousands of bottles of Temodar and temozolomide capsules, because cracks in the caps have rendered the child-resistant closure ineffective. Read More
The goal of the FDA’s quality metrics program is to share quantitative data with global regulators about the state of manufacturing quality, CDER Director Janet Woodcock said. Read More