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...]
FDA INSPECTION (Medisca) INITIATED FOR APIs FOLLOWING RECEIPT OF REPORTS FOR SERIOUS ADVERSE EVENTS (112515)
COMMENT:  Rarely does one observe such a flagrant number of mislabeled Active Pharmaceutical Ingredients (API) noted within a Warning Letter (Click Here). In this Warning Letter, two of six samples of L-Citrulline repackaged for distribution to Pharmacies for use in compounding were tested by the FDA found to not be as labeled. The firm … [Read more...]
CANCER CENTER RECEIVES FORM FDA 483 FOLLOWED BY WARNING LETTER A YEAR LATER FOR COMPROMISED ASEPTIC PROCESSING
Over the past several years, the FDA has cited a number of Compounding Centers for compromised aseptic processing. Often this has resulted in only a Form FDA 483. In other cases the actions have resulted in both a Form FDA 483 as well as a subsequent Warning Letter. The Johnson Memorial Cancer Center is one of those that has been cited for both through a 483Â and a … [Read more...]
Microbial Limits / Specified Microorganisms Rationale
As a “Frequently Asked Questionâ€, the USP is often queried about the determination of microbial limits and specified microorganisms. The following, obtained from USP, provides a clarification for this commonly asked question. In determining the appropriate microbial limit, the USP Microbiology Expert Committee considers such matters as the … [Read more...]
TESTING LABORATORY RECEIVES STERILITY OBSERVATIONS
FDA FINDS LABORATORY CONDUCTING STERILITY AND ENDOTOXIN TESTING FOR COMPOUNDING CENTERS HAS SIGNIFICANT ISSUES WITH STERILITY ASSURANCE The FDA recently audited Front Range Laboratories, Loveland, CO from August 5 through August 30, 2013. Their five investigators issued a five Observation, twelve page document. Enclosed is Observation 1 which … [Read more...]
