In our February 1st Issue, we highlight a specific 483-observation concerning rejected secondary packaging materials at a sterile-fill manufacturing facility. During the inspection, it was observed that rejected materials were being stored in two undesignated containers outside the facility. 

This 483 highlights the implications of improper storage of materials, posing a significant risk for contamination, cross-contamination, or accidental mix-ups, all of which could compromise the integrity of the product. 

In this particular 483 case, the observation was made during an inspection of a sterile-fill manufacturing facility, but his observation applies to all types of manufacturing operations. 21 CFR 211.89 states that: Rejected components, drug product containers, and closures shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.

The 483 for this company reads: 

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products. 

Specifically, … 

B. Inadequate Rejection Area

i. Your firm stored rejected primary containers and/or secondary labeling (pouches) within two undesignated storage containers on the outdoor grounds of the facility.

Separating all types of rejected materials is paramount for a quality system. It may seem trivial or innocuous that labeling pouches might be considered a controlled component in a manufacturing operation. FDA makes clear this is important for all types of materials and packaging supplies. Ensuring the quality and safety of storing of rejected materials, including primary containers and secondary labeling, such as pouches, will keep a firm out of hot water with FDA.  

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