Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September. 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 additional information or … [Read more...]
Porton Biopharma, Limited, Salisbury Received a Warning Letter (01/17/17)
Porton Biopharma, Limited, Salisbury received a Warning Letter following their most recent audit (View Link). Porton Biopharma, Limited, Salisbury, was audited from March 7-18, 2016 as a follow-up to an audit conducted January 12-23, 2015 wherein similar findings were observed. The repetition of these findings were observed to be so substantial that the FDA will … [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...]
Mylan Laboratories, India Receives Warning Letter (08/06/2015)
Significant Microbiological Issues were Observed The U.S. Food and Drug Administration (FDA) inspected the following three pharmaceutical manufacturing facilities between August 2014 and February 2015. February 6-13, 2015: Mylan Laboratories Limited OTL, Plot No. 284-B (19A) Bommasandra Jigani Link Road, Ind. Area, Anekal Taluk, Bangalore, 560 105 September 23, 2014 … [Read more...]
A REVIEW OF AN EXTENSIVE ENDOTOXIN WARNING LETTER USING THE NEW FDA “ENDOTOXIN” Q&A AS A BACKDROP
GENERAL The following Blog was initially published on October 1, 2012. Teva Parenterals Medicines had received a Warning Letter in December 2009 describing extensive issues with Endotoxin. To obtain more information on this subject, please plan to attend a webinar on Wednesday, September 9 sponsored by Tungsten Shield and COMMENT In … [Read more...]
