Food and Drug Administration officials uncovered about a dozen problems with how Global Pharma Healthcare made and tested its eyedrops during an inspection from late February through early March.
is considered particularly worrisome because the bacteria driving it is resistant to standard antibiotics.
The report has the agency’s preliminary findings and is likely to be followed by a formal report and a warning letter to the company. An FDA spokesman said the inspection indicates that the company’s products “may be in violation of FDA’s requirements.” The FDA is responsible for assuring the safety of foreign products shipped to the U.S., though it has long struggled to keep pace with international pharmaceutical supply chains that increasingly begin in India and China.FDA inspectors cited worrisome sanitary conditions at the Global Pharma plant, noting that its floors, walls and ceilings were not “easily cleanable.” At one point during the visit, an FDA inspector noted “none of the equipment on the filling machine was wrapped or covered.
Argentina Últimas Noticias, Argentina Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
Explainer: After COVID and drug shortages, EU revamps drug lawsThe EU is revamping laws governing the 136 billion euro ($148 billion) pharmaceuticals industry aimed at reviving investment and boosting access to affordable drugs at a time when health budgets have been drained by the costs of treating COVID-19.
Leer más »
Where exactly each dollar you spend on food goes: farmers get 14 cents and 4 cents pays for packagingA new report examines what each food dollar pays for, from food processing to packaging.
Leer más »
FDA plans to allow a second updated COVID booster for vulnerable AmericansThe FDA plans to allow older and immunocompromised Americans to get a second updated coronavirus booster shot in the near future, an acknowledgment of the virus’s continuing risks to vulnerable people.
Leer más »
Smoked salmon product recalled from Florida Publix supermarkets: FDASeven Seas International is recalling some of their Biltmore Smoked Sockeye Salmon products purchased in Publix stores before March 14, according to the Food and Drug Administration.
Leer más »
FDA finds dirty equipment, dozens of other issues at eye drops factory linked to deadly outbreakFederal inspectors found dozens of issues at an eye drops manufacturer now linked to a fatal outbreak of drug-resistant bacteria, inspection records released by the FDA show.
Leer más »
FDA inspection finds sterilization issues at recalled eye drop manufacturer's facility | CNNThe manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration.
Leer más »