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

Source: https://www.keypedia.com/records/warning_letter/asclemed-usa-inc/e9d25424-74f7-41e1-ac09-5ba35abf1058

> FDA WARNING_LETTER for asclemed usa inc.  on September 27, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: asclemed usa inc. 
- Inspection Date: 2018-09-27
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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

## Related Officers

- [Program Division Director](https://www.keypedia.com/people/steven-e-porter/5448db0e-32f0-4e98-8a5f-9f0857373b06)

Company: https://www.keypedia.com/companies/asclemed-usa-inc/a82d3d44-8e4e-4ea1-89b2-56beafb3d502

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6