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Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production control as well as not having established an adequate quality control unit, among other serious lapses.
The FDA rapped German pharmaceutical company B. Braun Medical for failing to thoroughly review unexplained batch discrepancies, a quality control unit that lacks the authority over drug products, failure to follow production and process control procedures, and other lapses observed during an inspection of the company’s Daytona, Fla., plant. Read More
The FDA dinged generics maker Cipla’s quality unit for several lapses, including failing to properly investigate batch discrepancies or the impact of power outages on drug product, during a Feb. 6-17 inspection of the company’s Madhya, Pradesh, India plant. Read More
Cosmoceutical Research Center was hit with a five-observation Form 483 following an inspection of its Panorama City, Calif., facility for lack of written quality control procedures, failing to test incoming components and several other lapses. Read More
ALI Pharmaceutical, a drug intermediate and active pharmaceutical ingredient (API) manufacturer in Omaha, Neb., was hit with a Form 483 for microbial contamination of products, failure to establish microbiological specifications for finished products and other lapses. Read More
Baudette, Minn.-based Ani Pharmaceuticals was hit with a six-observation Form 483 from the FDA that spotlights almost a year of ignoring customer complaints about products and not following its standard operating procedures (SOPs) for handling events that set off alarms in production.
Drugmakers may need to consult with their legal counsel during an FDA inspection so they know what the agency may legally request, according to inspection expert David Chesney, principal of DL Chesney Consulting. Read More
An October FDA inspection of Hattiesburg, Miss.-based Pharmacy Plus (also known as Vital Care Compounder) found multiple issues with product sterilization, including problems in the ISO 5 classified aseptic processing area. Read More
An Italian manufacturer of injectable drugs, Laboratorio Italiano Biochimico Farmaceutico Lisapharma, earned a Form 483 after an FDA inspection turned up evidence of microbiological contamination in supposedly sterile drugs.
Lyne Laboratories’ Brockton, Mass., drug manufacturing facility was handed a seven-observation Form 483 for inadequate investigations of complaints, lax batch records and other deficiencies. Read More
A federal court in Florida has issued a consent decree against LGM Pharma, a Boca Raton-based active pharmaceutical ingredient (API) importer and distributor, prohibiting the company from distributing APIs that don’t comply with current good manufacturing practices (cGMP). Read More