The company is voluntarily recalling all unexpired products that are intended to be sterile because of a lack of sterility assurance.
Premier Pharmacy Labs announced on June 18, 2019 that it was voluntarily recalling all unexpired products that were intended to be sterile because of a lack of sterility assurance. The recall follows an FDA inspection of the company’s Weeki Wachee, FL facility that found insufficient environmental controls, potential cross contamination, and a lack of process validation.
While the company has not received any reports of adverse events as of date, administration of nonsterile drug products that were intended to be sterile could result in serious infections. The company stated in a press release that the recall was being conducted out of an “abundance of caution.” Adverse events may be reported to FDA through its MedWatch program.
Source: FDA
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.