TOP FOUR OBSERVATIONS REMAIN SIMILAR IN NUMBER TO 2013 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 found within 21 CFR Part 211. Interestingly, … [Read more...]
VUAB PHARMA, CZECH REPUBLIC, RECEIVES WARNING LETTER (MAY 27, 2015, con’t)
Objectionable Bacillus spp. Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the … [Read more...]
THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s
TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR). It was completely “rolled out†in October 2002. For each “Objectionable Condition†(FDA 483 Observation), TurboEIR requests the inspection team to choose a … [Read more...]
CONTRACT PHARMACEUTICAL SERVICES OF AUSTRALIA PTY LTD (05/17/13) RECEIVES WARNING LETTER
HUMIDITY PLAYS A KEY ROLE IN THE PACKAGING OF A DRUG PRODUCT Contract Pharmaceutical Services of Australia was audited by the FDA from October 30 through November 1, 2012. The FDA identified significant violations of cGMP for finished pharmaceuticals during the visit. Based upon these violations, the drug products were deemed to be … [Read more...]
DPT LAKEWOOD, LLC LAKEWOOD, NJ RECEIVES FDA WARNING LETTER (08/27/12) FOR STERILITY FAILURES
DPT Lakewood, LLC was inspected between February 15 through March 7, 2012. During this audit the FDA found that Santyl Ointment to be adulterated and that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP. Specific violations observed … [Read more...]
