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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
The FDA hit Smithfield Bioscience with a Form 483 over unexplained batch discrepancies for its blood thinner heparin — a repeat observation from 2019 — following a July 2022 inspection of the company’s Cincinnati, Ohio, facility. Read More
During fiscal 2022, a period where the FDA ramped up its onsite drug inspections after a pandemic-era decline, the agency significantly targeted pharma companies for sterility-related concerns. Read More
The FDA issued a five-observation Form 483 to Tropical Seas’ over-the-counter drug manufacturing facility in Holly Hill, Fla., for inadequate testing and equipment maintenance, among other lapses observed in a July 11-15 inspection — including several repeat observations from a 2019 warning letter. Read More
An over-the-counter homeopathic anti-snoring nasal spray manufactured by Green Pharmaceuticals contained “gross microbial contamination,” including large numbers of the aerobic bacteria Providencia rettgeri, as well as yeast and mold, the FDA said in a warning letter to the company. Read More
The FDA handed Granules Pharmaceuticals’ Chantilly, Va., drug manufacturing facility a six-observation Form 483 for deficient quality control procedures and other production lapses following a July 18 to July 22 inspection. Read More