FDA WARNING_LETTER - asclemed usa inc. - September 27, 2018

On June 11, 2019, the FDA issued a Warning Letter to Asclemed USA Inc. dba Enovachem following an inspection from September 25-27, 2018, which identified significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (API). The facility's API were deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Failure to maintain complete traceability of API:** The company did not obtain or retain documents with the original manufacturer's identity and Certificates of Analysis (COA) for repackaged and distributed API. 2. **Failure to transfer all quality/regulatory information to customers:** COAs issued to customers for API like tramadol hydrochloride USP, testosterone USP, and estriol USP did not include the names and addresses of the original manufacturers. 3. **Failure to ensure necessary calibrations:** Scales used for weighing API were not appropriately calibrated (e.g., scale 5's calibration range did not bracket the intended use, and a weight used for verification was last calibrated in 2008). 4. **Failure to ensure regular quality reviews:** The firm lacked adequate records for annual periodic quality reviews of each drug, with records only showing meeting attendees but no details on information reviewed.

The FDA recommended engaging a qualified CGMP consultant and noted