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Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Read More
Elkhart-Ind.-based Voyant Beauty, a division of Accra-Pac, received an FDA warning letter on April 20 for not appropriately addressing benzene contamination of its over-the-counter topical aerosol products, found during an Aug. 23-Sept. 2, 2022 inspection. Read More
The FDA’s Office of Regulatory Affairs (ORA) needs technological advances to create “one source of truth” rather than the siloed data systems that currently hamper its efforts to modernize inspectional work, according to its chief. Read More
Problems related to written procedures occupy three spots in the FDA’s list of top 10 observations made in drug manufacturer inspections year after year: “procedures not in writing, fully followed,” “absence of written procedures” and “written procedures not established/followed.” Together, they represent 41.2 percent of all observations cited on FDA Form 483s to drugmakers in 2022. Read More
Double-checking that a Form 483 is factually correct — and that the observations make sense — are two of the most important things a firm can do when given the document, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar. Read More
The FDA rapped Omega Packaging Corp with a nine-observation Form 483 following an inspection of its Totowa, N.J., facility for deficient test methods and other lapses in its manufacture of hand sanitizers. Read More
Teva Pharmaceuticals was given a three-observation Form 483 following an inspection of its Fairfield, N.J., finished product manufacturing firm for inadequately cleaned and maintained equipment and other lapses. Read More
The FDA handed Defender SD Manufacturing a five-observation Form 483 following an inspection of its San Diego, Calif., facility for a quality unit that lacked authority to investigate errors, lack of written production procedures and environmental monitoring deficiencies, among other lapses. Read More
The FDA handed Advanced Accelerator Applications a five-observation Form 483 after conducting an inspection of its Millburn, N.J., facility for failure to establish written procedures for production and process controls for its drug products, and other lapses. Read More
Global Pharma Healthcare — the Chennai, India-based drugmaker that has issued two recent high-profile recalls of its eye drops for potential contamination — drew an 11-observation Form 483 from the FDA citing lax sterility practices and other deficiencies. Read More
The FDA dinged Dunagin Pharmaceuticals’ Rogers, Ark., drug manufacturing facility for its water system, its drug manufacturing and equipment cleaning processes, and for other deficiencies observed during an Aug. 29 to Sept. 2, 2022 inspection. Read More