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Lupin has been hit with a 10-observation Form 483 following an inspection of its Madhya Pradesh, India, drug manufacturing facility that revealed a failure to adequately handle out-of-specification results of batches that ended up on the U.S. market and remained there without “adequate justification.” Read More
The FDA has sent Champaklal Maganlal Homeo Pharmacy, located in Gujarat, India, a warning letter citing contamination issues after the agency’s Nov. 15, 2022, request for product testing records. Read More
The FDA handed APS Pharmacy a warning letter following the company’s response to a Form 483 that failed to address observations of the company’s compounding drug products using ineligible bulk drug substances. Read More
The FDA has issued a warning letter to Omega Packaging Corp. for failure to test active pharmaceutical ingredients for impurities and a lack of response from the company to this and other issues raised in a recent inspection. Read More
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