# FDA 483 - Allure Labs, Inc. - November 23, 2020

Source: https://www.keypedia.com/records/483/allure-labs-inc/0a4d594b-4a94-41cc-81f4-82dfbfcf4b4a

> FDA 483 for Allure Labs, Inc. on November 23, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Allure Labs, Inc.
- Inspection Date: 2020-11-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Allure Labs, Inc. in Hayward, CA, was inspected and cited for significant deficiencies across multiple systems. The inspection revealed failures in equipment cleaning validation and procedures, inadequate finished product testing for active ingredients, and a lack of stability data for product expiration dates. Additionally, the firm lacked scientifically sound sampling plans, written production and process controls, complete batch production records, and proper raw material identity testing and supplier validation.

## Related Documents

- [483 - 2021-12-03](https://www.keypedia.com/records/483/allure-labs-inc/3e977b5b-c7c8-482e-8c10-5adf49ef4b36)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)

Company: https://www.keypedia.com/companies/allure-labs-inc/e23e2739-c9b0-4f43-a2ce-81f30132d6b7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b