EXTENSIVE CORRESPONDENCE STILL RESULTS IN A WARNING LETTER During the time frame of March 25, 2013 through April 3, 2013 the FDA inspected Promed Exports Private Limited located at Promed Exports Private Limited, Khera Nihla Village, Tehsil Nalagarh, Solan District, Himachal Pradesh, 174101, … [Read more...]
BIOBURDEN CONTROL OF NONSTERILE DRUG SUBSTANCES AND PRODUCTS (USP)
A NEW PROPOSED USP GENERAL INFORMATION CHAPTER USP recently released a new DRAFT in a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP<1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES WARNING LETTER (05/31/13) — PART III
REPEAT VIOLATION CITES CRITICAL DEFECTS THAT CAN IMPACT PRODUCT STERILITY AND STABILITY The FDA recently audited two Baxter Healthcare facilities to include Marion, NC (November 7 to 16,2012) , and Jayuya, Puerto Rico (March 13, 2013 to April 19, 2013). Their Investigators identified significant violations of current good manufacturing practice (CGMP) regulations … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13) — PART II
WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [Read more...]
BAXTER HEALTHCARE CORP RECEIVES SINGLE WARNING LETTER FOR TWO LOCATIONS (05/31/13)
TOTAL MANAGEMENT COLLAPSE OF TERMINAL STERILIZATION OCCURS AT THE MARION, NC FACILITY BASED UPON FDA FINDINGS The FDA recently audited two Baxter Healthcare facilities to include Marion, NC (November 7 to 16,2012) , and Jayuya, Puerto Rico (March 13, 2013 to April 19, 2013). Their Investigators identified significant violations of current good manufacturing … [Read more...]
