FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES Microbiological consulting professionals  are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations. These … [Read more...]
FDA IGNORES CONSIDERATION OF WRITTEN RESPONSES IN DRAFTING WARNING LETTER
CEPHAZONE PHARMA'S (APRIL 25, 2011) INITIAL RESPONSE LACKS SUFFICIENT CORRECTIVE ACTION During our July 12, 2010 to August 26, 2010 inspection of your pharmaceutical manufacturing facility, Cephazone Pharma, LLC, located at 250 E Bonita Avenue, Pomona, CA, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of … [Read more...]
SOUTH DAKOTA PHARMACEUTICAL RECEIVES WARNING LETTER (3/17/11)
FDA CITES DAKOTA LABORATORIES FOR FAILURE TO ADEQUATELY VALIDATE ASEPTIC PROCESS Comment Excerpts and comments from specific violations follow. Please obtain the complete Warning Letter from FDA's web site. CGMP Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile … [Read more...]
CHINESE API MANUFACTURING FACILITIES RECEIVE WARNING LETTER (MARCH 30, 2011)
NINGBO SMART PHARMACEUTICAL RELEASE WITH INCOMPLETE C of As Comment The Ningbo Smart Pharmaceutical Co. Ltd, Ningbo China, received an Active Pharmaceutical Ingredient (API) audit between October 25-29, 2010. During this audit, the investigator identified significant deviations from CGMP for the manufacture of APIs. They … [Read more...]
FDA ISSUES WARNING LETTER FOR CLINICAL SUPPLY MANUFACTURING FACILITIES — FEBRUARY 10, 2011
Formatech, Inc Receives Warning Letter at Facility Manufacturing Clinical Trial Materials Comment: Clinical Supply Manufacturing (CMO) facilities are not customarily audited when they produce Phase 1, Phase 2 or Phase 3 Clinical Trial materials. A CMO would not typically receive its initial FDA audit until it requests its Pre-Approval Inspection (PAI) for a new drug. … [Read more...]
