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Potential contamination with foreign materials.
Lack of assurance of sterility. Bacterial contamination detected in some media fill units
Product contains undeclared milk.
Contains foreign objects (stones)
Undeclared Allergen (Soy)
Lack of Assurance of Sterility: Leaking/damaged syringes.
CGMP Deviations
Presence of Particulate Matter
inconsistent blending of iodine in the product
Potential contamination with foreign material (plastic)
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit