# FDA 483 - Elementis SRL, Inc. - March 17, 2022

Source: https://www.keypedia.com/records/483/elementis-srl-inc/cc64be0d-7f0a-4a90-8684-5c573ecf69de

> FDA 483 for Elementis SRL, Inc. on March 17, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elementis SRL, Inc.
- Inspection Date: 2022-03-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Elementis SRL, INC, an Active Pharmaceutical Ingredient manufacturer in Middletown, New York, received two observations during an FDA inspection. The firm's Quality Unit failed to conduct annual product reviews for API batches. Additionally, the quality unit did not fully investigate or resolve out-of-specification (OOS) results, attributing all root causes to operator error without implementing corrective or preventative actions.

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Company: https://www.keypedia.com/companies/elementis-srl-inc/47dc29b0-1f41-45b7-9e78-d941cb87ccd4

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