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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 issued a warning letter to Coram Healthcare over its Crownpoint, Ind., facility for serious deficiencies in producing sterile drug products. 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
Contract manufacturer Pernix Manufacturing received an 11-observation Form 483 for a litany of cGMP violations, including failing to investigate complaints about caterpillars and poppy seeds in vials of finished product. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
The House Energy & Commerce Committee is once again demanding information on the status of all patients in NIH clinical trials affected by the shutdown of the agency’s drug compounding facility, despite receiving a letter from NIH saying there were no negative impacts on affected patients. Read More
Despite having been closed for more than a year with no plan to reopen, the FDA issued a warning letter to Specialty Medicine Compounding Pharmacy for a litany of cGMP violations, including poor sterile processing controls. Read More