The US Food and Drug Administration (FDA) last month warned Vilvet Pharmaceuticals over good manufacturing practice (GMP) issues and for failing to list two of its products with the agency.   The warning letter comes after a 10-day inspection of Vilvet’s Chester Springs, PA facility in June 2018.   According to FDA, Vilvet failed to establish and follow adequate quality control practices, including failing to review batches of drugs made by a contract manufacturer....

The US Food and Drug Administration (FDA) this month warned Spanish over-the-counter (OTC) drugmaker Proandre SL over good manufacturing practice (GMP) and data integrity issues that landed the firm on import alert in November.   FDA inspected Proandre’s Barcelona facility over the course of four days last June, finding that its OTC Proandre antibacterial soap and hand sanitizer liquid are adulterated and misbranded. Two other products are cited in the warning letter a...

The US Food and Drug Administration (FDA) posted two warning letters on Monday that flagged a total of nine violations of good manufacturing practice (GMP) at California-based Total Thermal Imaging (TTI) and four violations of good laboratory practice (GLP) at an American Preclinical Services (APS) facility in Minneapolis. TTI’s warning letter comes after an FDA inspection of its website and brochures concluded that its Thermographic Business Package lacked the approv...

Getinge Group subsidiary Datascope failed to adequately conduct device design validation, establish procedures for corrective and preventive actions (CAPAs) and evaluate and select potential suppliers, according to a US Food and Drug Administration (FDA) warning letter. The warning letter was issued to the firm— acquired  by Getinge in 2008—on 6 February and made public Wednesday. It marks the second warning letter to the Getinge subsidiary. The first one was issued  l...

The US Food and Drug Administration (FDA) recently warned two drugmakers, Phoenix-based Vasco Rx and Commerce, CA-based Samson Pharmaceuticals, for good manufacturing practice violations at their facilities.   Vasco Rx   FDA’s warning letter to Vasco Rx comes after the agency inspected the company’s manufacturing site in March and April 2018.   At the end of the inspection in April, Vasco Rx stopped production and later voluntarily recalled all sterile drugs pr...

Earlier this month, the US Food and Drug Administration (FDA) confirmed the capabilities of Poland and Slovenia to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. FDA can now rely on a total of 22 member states to replace their own inspections, although the European Medicines Agency (EMA) notes that imported products still need to be batch tested until FDA recognizes all EU member states' authorities for human pharmaceuticals. ...

The US Food and Drug Administration (FDA) last month sent warning letters to Chinese over-the-counter (OTC) drugmaker Hangzhou Guoguang Touring Commodity Co. and the University of Miami Reproductive and Fertility Center.   Hangzhou Guoguang   The warning letter comes after FDA placed Hangzhou Guoguang on import alert in October following an inspection of the company's Zhejiang facility over four days last April.   According to the warning letter, Hangzhou Guog...

Unimed Pharma, a Slovakia-based pharmaceutical manufacturer, drew a statement of noncompliance after an inspection revealed two critical and 21 major good manufacturing practices (GMP) deficiencies. The statement of noncompliance took issue with the firm’s manufacturing operations for sterile products, including aseptically prepared small volume liquids and batch certification. The statement was issued by the Slovakian State Institute for Drug Control (SIDC), following ...

China-based Cao Medical Equipment drew a US Food and Drug Administration (FDA) warning letter after it continued to ship adulterated drugs despite promising to “immediately stop.”    The warning letter cites significant violations of good manufacturing practices at a facility in Hebei, China that resulted in adulterated drug products. It comes after the firm failed to ease FDA’s concerns in its response to a July Form 483. The firm was placed on import alert last month...

The US Food and Drug Administration (FDA) on Wednesday finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency’s current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in thei...

The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to clarify provisions that became applicable to outsourcing facilities, following the 2013 enactment of section 503B under the FD&C Act that allowed drug compounders to register as outsourcing facilities with FDA. Outsourcing facilities must be GMP compliant and are subject t...

A US Food and Drug Administration (FDA) inspection at the McPherson, KS plant of Pfizer’s Hospira business revealed seven repeat FDA Form 483 citations dating back to 2012. FDA investigators conducted an inspection of the human sterile drug manufacturing site from late July to early August 2018, with the agency posting the Form 483 to its website Friday. The latest 483 comes after Hospira’s Kansas plant drew an FDA warning letter last year, with significant violations...