# FDA 483 - Stoll Metalcraft Inc - October 11, 2023

Source: https://www.globalkeysolutions.net/records/483/stoll-metalcraft-inc/9933fd59-098e-4ff3-a2e1-91db972cdc26

> FDA 483 for Stoll Metalcraft Inc on October 11, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stoll Metalcraft Inc
- Inspection Date: 2023-10-11
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Stoll Metalcraft Inc, a Class II medical device contract manufacturer in Valencia, CA, was inspected by the FDA. The inspection revealed two significant observations related to quality system deficiencies. These included inadequate documentation of out-of-calibration equipment evaluations and incomplete device history records.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/stoll-metalcraft-inc/f60e430d-46f5-42c8-84b0-7dabc4ae05ce

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6