# FDA 483 - Kiltex Corporation - September 27, 2018

Source: https://www.globalkeysolutions.net/records/483/kiltex-corporation/daa9a379-5f9d-4bd8-bc59-24c7689b8d68

> FDA 483 for Kiltex Corporation on September 27, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kiltex Corporation
- Inspection Date: 2018-09-27
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Klitex Corporation, a medical device manufacturer in Akron, OH, received a Form FDA 483 with two observations. The inspection revealed inadequate control over production processes, specifically regarding temperature monitoring and record accuracy, and a lack of established agreements with suppliers for notification of product or service changes.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/kiltex-corporation/a1fb0c1e-b682-403b-a339-7607966a4284

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22