FDA 483 - Kalman Health & Wellness, Inc. - September 01, 2016

This FDA Form 483 document details multiple deficiencies observed during an inspection, primarily concerning the manufacturing of sterile drug products. The facility's procedures for preventing microbiological contamination lack adequate validation of the sterilization process. Separate or defined areas necessary to prevent contamination or mix-ups are deficient. Aseptic processing areas exhibit deficiencies in their cleaning and disinfecting systems for equipment, and environmental monitoring systems. Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals.

Further issues include the lack of retesting or re-examination of approved components and closures after exposure to adverse conditions. Batch production and control records are incomplete. Protective apparel is not consistently worn to prevent drug product contamination. Drug product containers are not adequately sterilized and processed for pyrogenic properties. Components liable to microbiological contamination are not subjected to microbiological tests before use. Each batch of sterile and pyrogen-free drug product is not laboratory tested for conformance. Drug product release testing does not include appropriate laboratory determination of active ingredient identity and strength. Finally, there is no written stability testing program for drug products, and routine equipment calibration is not performed according to a written program.