# FDA 483 - Evaric Pharmaceuticals Inc. - March 01, 2021

Source: https://www.keypedia.com/records/483/evaric-pharmaceuticals-inc/d0eacb43-309d-43c7-9db0-271c05fec4cf

> FDA 483 for Evaric Pharmaceuticals Inc. on March 01, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evaric Pharmaceuticals Inc.
- Inspection Date: 2021-03-01
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Evaric Pharmaceuticals Inc. in Hauppauge, NY, was cited for significant deficiencies in its manufacturing processes and quality controls. Observations included a lack of written procedures for production and process controls, unqualified relocated equipment, and deficient batch production records with inconsistent documentation. Additionally, the firm failed to properly clean equipment, leading to soiled utensils with residue.

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## Related Officers

- [Bijoy Panicker](https://www.keypedia.com/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.keypedia.com/companies/evaric-pharmaceuticals-inc/0f29a015-1b48-40b9-a0a7-04ec9c3e15b4

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961