Biological Controls – FDA Warning Letter, Nov 30, 2009

On November 17-30, 2009, an FDA inspection of Biological Controls in Eatontown, NJ, revealed that their MICROCON air purification devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). The firm's December 16, 2009, response to the FDA 483 was deemed inadequate.

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR § 820.100(a))**: The Corrective Action for Failed Components procedure lacks requirements for analyzing quality data sources, and the CAPA form does not specify verification/validation of effectiveness. This is a repeat violation. 2. **Failure to establish and maintain design control procedures (21 CFR § 820.30(a))**: No procedures exist to control the design process or ensure design requirements are met for devices like the MICRON 400 UV & 800 UV. 3. **Failure to establish and maintain procedures for design change control (21 CFR § 820.30(i))**: No procedures for identifying, documenting, validating, reviewing, and approving design changes made in May/June 2