# FDA 483 - ARSCI INC. - October 30, 2014

Source: https://www.keypedia.com/records/483/arsci-inc/f6457175-f525-42da-ae9a-08fddcb97cbd

> FDA 483 for ARSCI INC. on October 30, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARSCI INC.
- Inspection Date: 2014-10-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Jieying Laboratory Inc. in Longueuil, Quebec, Canada, was inspected by the FDA from October 27-30, 2014. The inspection revealed significant deficiencies across its quality system, particularly concerning the lack of established procedures for design control, process validation, acceptance activities, change control, device master records, device history records, equipment calibration, sampling methods, CAPA, labeling, nonconforming product, complaint handling, quality audits, and employee training. These widespread issues indicate a severely underdeveloped quality management system for a manufacturer of products used in in-vitro fertility procedures.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/arsci-inc/02dc7f19-0a3b-4e3f-9003-24730dd7c9b1

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd