# FDA 483 - Starkey Laboratories Inc - November 13, 2018

Source: https://www.globalkeysolutions.net/records/483/starkey-laboratories-inc/4a3bb024-14ff-457a-8581-fe581e678857

> FDA 483 for Starkey Laboratories Inc on November 13, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Starkey Laboratories Inc
- Inspection Date: 2018-11-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Starkey Labs Inc in Eden Prairie, MN, conducted from November 7-13, 2018, identified a significant deficiency related to document control. The firm failed to adequately establish and implement procedures, specifically lacking documented approvals for critical manufacturing procedures and software validation plans for RTA machines. This indicates a moderate severity issue concerning the firm's quality system.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/starkey-laboratories-inc/b547bdab-e144-4d52-b606-9e060b2758eb

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d