All Recalls

The firm was informed by their customer that a random sample tested by the FDA test positive for norovirus.

Yeast presence that resulted in gas formation causing bottles to bloat and release mayonnaise.

Stagno's Bakery, Inc. initiated a recall on 05/24/2019 of wholesale frozen bagel dough / bulk to one direct account because the product is potentially contaminated with E. Coli .

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Lack of Assurance of Sterility.

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Lack of Assurance of Sterility.

Lack of Assurance of Sterility.

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Lack of Assurance of Sterility.

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.