# FDA 483 - Surgisil, LLP - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/surgisil-llp/a580d576-c60c-42d3-bc04-d4d545c79b6e

> FDA 483 for Surgisil, LLP on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Surgisil, LLP
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of SurgiSil, LLP in Plano, TX, a device manufacturer, revealed significant deficiencies in its quality system. Observations included failures to implement and verify corrective and preventive actions, lack of regular quality audits, and inadequate employee training procedures. These issues indicate a breakdown in the firm's ability to maintain an effective quality system.

## Related Documents

- [WARNING_LETTER - 2018-09-25](https://www.globalkeysolutions.net/records/warning_letter/surgisil-llp/1e65c1b9-cdbd-46db-ac94-78a75a78e4cf)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

Company: https://www.globalkeysolutions.net/companies/surgisil-llp/34f4f5fe-a1d4-4a86-bf11-efa4ef83da96

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab