# FDA 483 - Alcami Corporation - August 23, 2016

Source: https://www.globalkeysolutions.net/records/483/alcami-corporation/5cb370a2-b7b4-422f-8db2-31b601719afe

> FDA 483 for Alcami Corporation on August 23, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcami Corporation
- Inspection Date: 2016-08-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Alcomi Corporation, a contract testing laboratory in Edison, NJ, was cited for inadequate laboratory controls during an FDA inspection. The firm failed to establish scientifically sound and appropriate test procedures, specifically by not fully adhering to USP <81> for microbial assays of antibiotics. This indicates a significant deficiency in ensuring the identity, strength, quality, and purity of drug products.

## Related Officers

- [Tonia F. Bernard](https://www.globalkeysolutions.net/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)
- [Investigator ](https://www.globalkeysolutions.net/people/marie-buen-bigornia/0d363d83-b630-447d-8766-09c8f85665a7)

Company: https://www.globalkeysolutions.net/companies/alcami-corporation/767be483-4965-4851-96ba-eeb327533905

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248