The terms contamination and cross contamination are referenced more than 25 times throughout CFR-Code of Federal Regulations Title 21 in the following areas:

• Sec. 211.28 Personnel responsibilities.
• Sec. 211.42 Design and construction features.
• Sec. 211.46 Ventilation, air filtration, air heating and cooling.
• Sec. 211.48 Plumbing.
• Sec. 211.56 Sanitation.
• Sec. 211.67 Equipment cleaning and maintenance.
• Sec. 211.80 General requirements.
• Sec. 211.82 Receipt and storage of untested components, drug product containers, and closures.
• Sec. 211.84 Testing and approval or rejection of components, drug product containers, and closures.
• Sec. 211.94 Drug product containers and closures.

Needless to say the FDA take contamination extremely seriously as they understand and know what impact it can have on patient safety.