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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
Plainville, Conn.,-based AllerQuest, maker of the sterile PRE-PEN Injection — a drug that tests for penicillin allergy before administering a dose of penicillin — was hit with an 11-observation Form 483 for failure to isolate operators from aseptic filling equipment, poor airflow and other lapses. Read More
Intas Pharmaceuticals was hit with a 36-page, 11-observation Form 483 following an inspection of its facility in Ahmedabad, India, that reads like a comedy of errors. Read More
Marcus Research Laboratory of St. Louis, Mo., was slapped with a nine-observation Form 483 for deficiencies ranging from walls and floors so covered in the facility’s active pharmaceutical ingredient (API) that one investigator’s feet got stuck to the floor, to batch production records missing several key steps. Read More
Last year’s decision by HHS to limit payment for Biogen’s controversial Alzheimer’s drug Aduhelm to patients in a clinical trial could have a long-term negative effect on the entire accelerated approval (AA) pathway, said former FDA Commissioner Scott Gottlieb. Read More
The FDA sent a warning letter to Global Pharmacy Plus, an internet pharmacy, concerning the company’s marketing of generic versions of the immunosuppressant drugs mycophenolate mofetil and tacrolimus, both of which carry Black Box warnings and must only be distributed under an approved Risk Evaluation and Mitigation Strategy (REMS). Read More