# FDA 483 - PediaLift LLC - January 12, 2018

Source: https://www.globalkeysolutions.net/records/483/pedialift-llc/974605d5-3837-46a7-9c71-9b5a3acd173c

> FDA 483 for PediaLift LLC on January 12, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PediaLift LLC
- Inspection Date: 2018-01-12
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of PediaLift LLC, a medical device manufacturer in Mansfield, OH, revealed significant deficiencies across its quality system. The firm failed to establish fundamental procedures for design controls, including design input, output, verification, validation, change, and transfer. Additionally, the inspection found a lack of procedures for quality audits, medical device reporting, device master records, device history records, supplier agreements, supplier evaluations, and document control, indicating a pervasive absence of a robust quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.globalkeysolutions.net/companies/pedialift-llc/13c795f0-3646-4b10-b2f4-67bfa1c93aaf

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