# FDA 483 - Asclemed USA Inc. dba Enovachem Pharmaceuticals - September 25, 2018

Source: https://www.keypedia.com/records/483/asclemed-usa-inc-dba-enovachem-pharmaceuticals/ccf2a7b4-c2c7-4665-9a4d-826fc53bb90e

> FDA 483 for Asclemed USA Inc. dba Enovachem Pharmaceuticals on September 25, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Inspection Date: 2018-09-25
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Asclemed USA Inc., dba Enovachem, a packer/repacker in Torrance, CA, received a Form 483 with three observations during an inspection from September 25-27, 2018. The observations primarily concern deficiencies in equipment calibration, lack of written procedures for annual product evaluations, and incomplete Certificates of Analysis for repackaged APIs. These issues indicate potential gaps in quality control and documentation practices.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/asclemed-usa-inc-dba-enovachem-pharmaceuticals/4accbf56-7f89-4c0a-8196-1290061fb20e

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