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In a March 22 to April 12 inspection of a sterile drug manufacturing facility in Santa Barbara, Calif., the FDA investigator observed the presence of non-microbial contamination in the storage and mixing room, among other quality issues. Read More
Japanese drugmaker Toyobo failed to adequately investigate why batches of a sterile injectable drug it makes were repeatedly contaminated with particles, the FDA said in a warning letter to the company. Read More
FDA investigators observed during a March 24 to April 9 inspection of Ampak Chemical’s Carson, Calif., facility that it lacked a quality unit to oversee drug manufacturing. Read More
An FDA inspection of an Eli Lilly manufacturing facility in Indianapolis, Ind., earlier this year observed inadequate environmental monitoring in aseptic processing areas, among other quality lapses, the agency said in a Form 483 inspection report that was just publicly released. Read More
The FDA is working on new ways to monitor overseas drug manufacturing plants to alleviate the crippling inspection backlog it faces due to COVID-19 and is reaching outside the agency for a new pilot program. Read More
The Ziverdo Kit, consisting of zinc acetate, doxycycline and ivermectin, was falsely marketed as a first-line treatment for COVID-19, the FDA said. Read More
FDA investigators observed various quality deficiencies during inspections of drug manufacturing facilities in North Carolina, Kansas, Florida and California. Read More
The FDA issued a warning letter to generic drugmaker Lupin for good manufacturing practice (GMP) violations observed during an inspection of its plant in Somerset, New Jersey. Read More
The FDA has given Emergent BioSolutions’ Bayview, Md., facility the green light to restart manufacturing Johnson & Johnson’s (J&J) COVID-19 vaccine — months after new production was put on hold following the discovery of numerous quality issues and cross-contamination with AstraZeneca vaccine doses. Read More
An FDA inspection of PF Consumer Healthcare’s Guayama, Puerto Rico facility revealed good manufacturing practice deficiencies including a failure to fully investigate complaints of broken, chipped or crushed tablets. Read More
An FDA inspection of Nostrum Laboratories’ Lenexa, Kansas facility found that it failed to properly identify and track bottles containing low pill counts after the company received complaints earlier in the year. Read More