# FDA 483 - Brand-Nu Laboratories, Inc. - November 22, 2021

Source: https://www.keypedia.com/records/483/brand-nu-laboratories-inc/f2dac3ef-670a-47de-ba3e-3a94c71ac953

> FDA 483 for Brand-Nu Laboratories, Inc. on November 22, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Brand-Nu Laboratories, Inc.
- Inspection Date: 2021-11-22
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Brand-Nu Laboratories, LLC, an API/Excipient repacker in Meriden, Connecticut, was inspected by the FDA. The inspection revealed significant issues with the firm's quality control unit, specifically regarding the failure to follow written procedures for cleaning, environmental monitoring, and annual product reviews. Additionally, the firm failed to ensure employees received documented annual cGMP training.

## Related Documents

- [483 - 2021-11-22](https://www.keypedia.com/records/483/brand-nu-laboratories-inc/38476cf1-beb0-472c-a7f4-6385b83a617d)

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.keypedia.com/companies/brand-nu-laboratories-inc/dcaff880-0e9b-4a20-b915-325f34a72c4f

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