# FDA 483 - First Call, Inc. - July 19, 2019

Source: https://www.globalkeysolutions.net/records/483/first-call-inc/5f5f61cf-cb86-4a6c-bacb-d4d35f39f048

> FDA 483 for First Call, Inc. on July 19, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Call, Inc.
- Inspection Date: 2019-07-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: First Call, Inc., a manufacturer of the Class II Suturing Washer device in Winona Lake, IN, was cited for multiple quality system deficiencies during an FDA inspection. Observations included the failure to establish a design history file, inadequate procedures for supplier quality, lack of Unique Device Identifier (UDI) in device history records, and a lack of independence in internal quality audits. These issues indicate significant non-compliance with medical device quality system regulations.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.globalkeysolutions.net/companies/first-call-inc/6f411289-5386-4c3a-9ec1-41e3ef3c81de

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0