Tag Archives: Warning Letter

FDA Warning Letters – Their Relationship to Drug Shortages

The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public.  Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA … Continue reading

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NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS

CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Products and for Active Pharmaceutical Ingredients.  Please … Continue reading

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IMPORT ALERT FINDING GREATER USAGE WITHIN FDA’S BAG OF “WEAPONS”

GULF PHARMACEUTICAL INDUSTRIES (02/23/12), NOBILUS ENT (03/07/12) and LABORATORIOS JALOMA S.A. de C.V. (03/9/12) ALL RECEIVE IMPORT ALERTS WITHIN ONE MONTH AS PART OF THEIR WARNING LETTERS The FDA has recently begun to use within their CDER Warning Letters the following terminology on a … Continue reading

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WINTAC LIMITED INDIA RECEIVES FDA WARNING LETTER (022312)

CITES ASEPTIC MANUFACTURING FACILITY FOR SIGNIFICANT cGMP VIOLATIONS Specific violations observed during the inspection include, but are not limited, to the following: 1. Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug … Continue reading

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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 … Continue reading

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WARNING LETTER SANOFI AVENTIS DEUTSCHLAND GmbH

WARNING LETTER  FEBRUARY 9, 2011 SANOFI AVENTIS DEUTSCHLAND GmbH (con’t) 2. Your firm has not established separate or defined areas or such other control systems as necessary to prevent contamination or mix-ups during aseptic processing. [21 C.F.R. § 211.42(c)]. For example,  a) The airflow velocity inside critical … Continue reading

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Steris Corporation Warning Letter February 9, 2011

 Warning Letter  February 9, 2011 Steris Corporation “Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)” Comment Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical … Continue reading

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Baxter Healthcare Puerto Rico Warning Letter 1/20/11

Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 2. Your firm failed to ensure your container closure system provided adequate protection against foreseeable external factors in storage and use that … Continue reading

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Baxter Healthcare Puerto Rico Jayuya Warning Letter 1/20/2011

Warning Letter January 20, 2011 Baxter Healthcare Puerto Rico 1. The Jayuya Facility (Puerto Rico) A. CGMP Violations 1. Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether … Continue reading

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Baxter Healthcare Corp Puerto Rico Warning Letter – Just Issued

The FDA just announced the Warning Letter for Puerto Rico -  Comments to follow Baxter Healthcare Corporation 1/20/11     Department of Health and Human Services Public Health Service Food and Drug Administration   San Juan District 466 Fernandez Juncos … Continue reading

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