The U.S. Food and Drug Administration (FDA) inspected Celltrion Inc, Republic of Korea from May 22 – June 2, 2017. On January 26, 2018 the FDA issued a Warning Letter for microbiological/environmental issues that summarizes significant violations of cGMP for finished pharmaceuticals (see 21 CFR, parts 210/211). Several … [Read more...]
Compounding Pharmacies’ Observations Correlate With Those From Large Pharma ISO 5 Facilities
Compounding pharmacies continue to receive citations from the FDA (both Form FDA 483s and Warning Letters) for a continuing failure to meet 21 CFR 210/211 requirements. All one needs to do is visit FDA’s Electronic Reading Room to learn of the ORA audits and the subsequent citations. Even after the New England Compounding Center … [Read more...]
2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program
7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been … [Read more...]
PHARMACEUTICAL FIRM RECALLS NASAL SPRAY FOR POTENTIAL MICROBIAL CONTAMINATION (10/02/13)
NEPHRON PHARMACEUTICALS APPLAUDED FOR PROACTIVE STANCE Nephron Pharmaceuticals Corporation, Orlando, FL (NPC) recalled 689,568 cartons (ten lots) of Albuterol Sulfate Inhalation Solution for oral inhalation. The recall, which was initiated by the firm and was voluntary, was caused by a “Lack of Assurance of Sterility: … [Read more...]
ANOTHER INDIAN FACILITY RECEIVES WARNING LETTER FOR POOR ASEPTIC PROCESSING
FDA QUESTIONS FIRM’S BASIC UNDERSTANDING AND MICROBIAL CONTROLS CRITICAL FOR THE MANUFACTURE OF STERILE PRODUCTS Agila Specialties Private Ltd, located at Bommasandra Jigani Link Rd., Bangalore, India was audited by the FDA from June 17 to June 27, 2013. The audit resulted in the FDA continuing to consider their Import Hold on this facility. Significant Observations included … [Read more...]
