# FDA 483 - Celfa s.c. - July 20, 2018

Source: https://www.keypedia.com/records/483/celfa-sc/c68cee7a-f604-4113-ab0e-0faa45b313f4

> FDA 483 for Celfa s.c. on July 20, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Celfa s.c.
- Inspection Date: 2018-07-20
- Product Type: devices
- Office Name: New England District Office
- Summary: Medical device manufacturer Celfa s.c., based in Verona, Italy, was subject to an FDA inspection from July 12 to July 20, 2018. The inspection, conducted under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, resulted in one significant observation documented on a Form FDA 483.

The main issue identified concerned the inadequate establishment of procedures for the acceptance and control of in-process products. Specifically, the FDA investigator noted that failing in-process testing results for the beam limiter sub-assembly (part number 96600870) were not retained within the device history record. Furthermore, there was no documented reference indicating where these crucial testing results could be obtained. This represents a lapse in maintaining complete and accessible quality control documentation, essential for ensuring product quality and traceability.

In response to this observation, Celfa s.c. committed to correcting the identified deficiency. The issuance of an FDA 483 requires the firm to take prompt and effective corrective actions to address the noted violations of quality system requirements and ensure full compliance with regulatory standards.

## Related Documents

- [483 - 2018-07-20](https://www.keypedia.com/records/483/celfa-sc/73d48240-2a8b-4daa-9e1e-6e0a5a7ea4cb)

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.keypedia.com/companies/celfa-sc/22da8ec0-ed7f-46f0-b149-cc6e7b11ebc8

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144