# FDA 483 - LaunchWorks LLC - October 23, 2019

Source: https://www.globalkeysolutions.net/records/483/launchworks-llc/7efd0e36-6a5b-40c2-9140-2c8027d45aa6

> FDA 483 for LaunchWorks LLC on October 23, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LaunchWorks LLC
- Inspection Date: 2019-10-23
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Launchworks Manufacturing Lab in Beverly, MA, a manufacturer of newborn screening test systems, identified one significant observation. The firm failed to establish procedures for controlling environmental conditions in its clean room, which was also not certified annually as required. This indicates a lapse in quality system requirements related to environmental control.

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.globalkeysolutions.net/companies/launchworks-llc/67677098-7988-4a1e-87e0-f2d5ed20a98c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7