# FDA 483 - Cetro America Inc. - January 11, 2018

Source: https://www.keypedia.com/records/483/cetro-america-inc/40797fe8-5154-4c8c-bf7e-236f3609c5ad

> FDA 483 for Cetro America Inc. on January 11, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cetro America Inc.
- Inspection Date: 2018-01-11
- Product Type: other
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Cetrix America in Wallingford, CT, a specifications developer and initial importer, revealed a significant lack of established quality system procedures. The firm was cited for not having written procedures for the establishment and maintenance of a quality system, including a quality manual and procedures for corrective and preventive actions, complaint handling, and servicing. This indicates a fundamental deficiency in the firm's quality management system.

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## Related Officers

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Company: https://www.keypedia.com/companies/cetro-america-inc/425c796a-3b5b-4618-a7e4-03649bb4ba5e

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94