# FDA 483 - Eisertech LLC - August 21, 2019

Source: https://www.globalkeysolutions.net/records/483/eisertech-llc/5bd72346-8c01-452c-a7b4-06c58a73c049

> FDA 483 for Eisertech LLC on August 21, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisertech LLC
- Inspection Date: 2019-08-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Eicotech LLC, a medical device manufacturer in San Diego, CA, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions (CAPA) and a complete lack of established procedures for receiving, reviewing, and evaluating complaints. These issues indicate a fundamental weakness in the firm's quality management processes.

## Related Officers

- [Wilfred A. Darang](https://www.globalkeysolutions.net/people/wilfred-a-darang/f0f1e653-891d-47d6-82e3-5ce40a5d3635)

Company: https://www.globalkeysolutions.net/companies/eisertech-llc/4a496f99-fb06-4cfe-b213-91cbc640aad2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e