FDA 483 - In Your Atmosphere Holdings LLC - January 19, 2017

An FDA inspection conducted from January 9-19, 2017, at In Your Atmosphere Holdings LLC, a producer of non-sterile drug products in Santa Fe, NM, revealed significant deviations from current Good Manufacturing Practices (GMP). The observations highlight critical deficiencies in quality control, process management, and product testing. Key issues included a lack of detailed written procedures for equipment cleaning and maintenance, failing to ensure effective sanitization and prevent cross-contamination, especially for highly active compounds. The firm also lacked a defined quality control unit with documented responsibilities, including the approval and rejection of procedures and product release. Laboratory controls were insufficient, with no testing for identity, strength, purity, or composition for most formulations and incoming components. Supplier qualification was absent, and raw materials were released without adequate testing. Furthermore, the inspection noted a lack of written production and process controls, unassessed equipment qualifications, and unperformed process validation for numerous formulations. Equipment calibration records were missing, and critical temperature-sensitive storage lacked documented calibration. Drug products were assigned Beyond Use Dates (BUDs) without supporting stability data. Finally, employees, including pharmacists and technicians, had not received documented GMP training since the company's inception in 2014. In response to these findings, In Your Atmosphere Holdings LLC is required to implement comprehensive corrective and preventive actions to address each observation and ensure compliance with FDA's GMP regulations for drug manufacturing.