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The FDA cited FMK Labs for deficiencies in its standard operating procedures during an Oct. 16-22 inspection of its Corona, California facility. Read More
Sterile drug manufacturer Horizon Pharmaceuticals found itself in the agency’s crosshairs for violations at its Riviera Beach, Florida Facility, receiving a Form 483 for issues found at its facility. Read More
“Without this testing, you do not have scientific evidence that all drug product batches you manufactured meet their established specifications prior to release,” the agency said. Read More
The FDA cited Johnson Memorial Cancer Center’s Enfield, Connecticut sterile drug manufacturing facility after investigators found sterility problems, airflow issues and mold contamination during an Oct. 1 to Oct. 19 inspection. Read More
The FDA hit Chinese manufacturer CAO Medical Equipment with a warning letter citing drug and API testing violations at its Langfang, Hebei facility. Read More
The FDA handed BASF a Form 483 after finding that the drugmaker’s Quincy, Florida, facility put its API products at risk of contamination and failed to follow procedures for OOS results. Read More
The FDA also cited the compounder for labeling violations for products lacking the required labeling statements “This is a compounded drug” or “Not for resale.” Read More
“In addition, your firm failed to have written procedures for re-evaluating the cleaning validation program upon entrance of new active ingredients in the manufacturing facility,” the agency said in the Form 483, adding that the firm did not consistently perform risk assessments on drug substances manufactured on shared equipment — such as reviewing each new drug substance’s toxicological data, solubility and pharmacological effects. Read More
Gottlieb said the agency is “going to be putting many more firms on notice that we’re aware that they’re manufacturing cell and tissue products that are subject to our oversight.” Read More