Enclosed are a series of upcoming microbiological related webinars which are being offered between now and the middle of June. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain … [Read more...]
NIPPON FINE CHEMICAL CO RECEIVES IMPORT ALERT AND WARNING LETTER FOR REFUSAL TO ADMIT
Nippon Fine Chemical recently received a Form FDA 483 (December 14, 2015), followed by an Import Alert (August 8, 2016) and a Warning Letter (Click Here) (September 26, 2016) for adulterated products that were produced at their drug manufacturing facility, Nippon Fine Chemical Co., Ltd, located at 1-1, 5-Chome, Umei, Takasago City, Hyogo. The FDA investigator documented that … [Read more...]
FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2015 – NOW AVAILABLE
TOP FOUR OBSERVATIONS RETAIN SIMILAR ORDER TO 2013 AND 2014 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc. This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those FDA' CDER listing found within 21 CFR Part … [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...]
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...]
