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potential for pieces of metal in product
cGMP Deviations
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).
Products contain undeclared allergens (milk, soy, peanut, and wheat) and undeclared sulfites, yellow 5, yellow 6, and red 40)
Salsa had pH of 4.7.
Elevated lead > 2ppm
BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).