FDA WARNING_LETTER - Sircle Laboratories, LLC - April 26, 2021

The FDA inspected Sircle Laboratories, LLC, from April 13-26, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated. The firm's May 11, 2021, response to the FDA 483 was reviewed.

Key violations include: 1. **Quality Control Unit Failures (21 CFR 211.22):** The quality control unit failed to ensure drug products complied with CGMP and specifications. This involved inadequate oversight of Contract Manufacturing Organizations (CMOs), leading to the use of sub-standard CMOs (some previously cited by FDA). The firm lacked batch release procedures for CMO-manufactured products and failed to follow its own change control procedures for consumer complaints, recalls, and labeling. The FDA requires a comprehensive assessment plan for supplier qualification and oversight, a remediation plan for the quality unit's authority and resources, and a retrospective review of all batches in the U.S. market. 2. **Inadequate Complaint Handling (21 CFR 211.198(a)):** The firm failed to establish and follow adequate written procedures for handling complaints. Designated staff titles in procedures did not exist, and the firm did not provide evidence that the revised responsible individual follows the procedure or assesses serious adverse events. The FDA requires a retrospective assessment of complaints, a list of all complaints, and procedures for