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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
An FDA inspection of Merck’s Durham, N.C., plant revealed lapses of good manufacturing practices for equipment and building maintenance, as well as problems with process controls and records. Read More
An FDA inspection of an over-the-counter drug manufacturing facility in Torrance, Calif., found failures to follow written cleaning and maintenance procedures as well as recordkeeping and testing lapses. Read More
Diamond Wipes International, a manufacturer of medicated wipes, drew a Form 483 with six observations following an FDA inspection at its Chino, Calif., manufacturing facility. Read More
An FDA inspection of Dr. Reddy’s active pharmaceutical ingredient (API) manufacturing plant in Middleburgh, New York earlier this year found lapses in good manufacturing practice (GMP). Read More