FDA 483 - Choice All Natural, Inc. dba Om Botanical - May 03, 2022

During an inspection conducted from April 25 to May 3, 2022, the FDA issued a Form 483 to Steri-Tech, Inc., a medical device manufacturer in Brighton, MI. The inspection identified significant deficiencies in the company's quality management system, with several observations being repeats from an August 2018 inspection. Main violations included a failure to establish adequate procedures for corrective and preventive actions (CAPA), specifically lacking requirements for analyzing quality data. The firm also had not conducted process validation for its sterile surgical tubing's sterilization process. Complaint handling procedures were found to be inadequate, as they did not ensure uniform processing or documentation of oral complaints. Additionally, Steri-Tech, Inc. lacked established procedures and had not performed design validation for its Class II sterile suction/irrigation surgical tubing and Class I non-sterile Yankauer suction tube sets. Supplier control was deficient, with no quality agreement in place for the contract sterilizer and no defined requirements for critical component suppliers. Lastly, the company had not conducted any management reviews since 2018. These observations indicate non-compliance with various sections of 21 CFR Part 820, the Quality System Regulation for medical devices, highlighting a critical need for comprehensive corrective actions to ensure product quality and regulatory adherence.