We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA hit Swedish drug manufacturer Apotek Produktion & Laboratorier with a Form 483 for failure to reject inadequate drug products and to secure analytical equipment at its facility in Stockholm. Read More
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