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 frequent basis.  This includes “….until such time as your manufacturing practices are verified to comply with CGMPs, your firm will remain under FDA Import Alert, and FDA will continue to refuse admission of all articles manufactured at ‘YOUR FIRM’ (Gulf Pharmaceutical Industries, Nobilus Ent, Laboratorios Jaloma S.A. de C.V.)…into the United States.”

Please review each of the Warning Letters at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm for additional details.

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About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods
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