US FDA Contamination control findings

Beta-lactam drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

Microbial contamination was present in the.

Contamination was observed in your production area and areas adjacent to production areas.

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.

Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.