# FDA WARNING_LETTER - Jieying Laboratory Inc - October 30, 2014

Source: https://www.keypedia.com/records/warning_letter/jieying-laboratory-inc/41204700-ab75-4eea-adb6-7f01c4b5cd2d

> FDA WARNING_LETTER for Jieying Laboratory Inc on October 30, 2014. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Jieying Laboratory Inc
- Inspection Date: 2014-10-30
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: On March 9, 2015, the FDA issued a Warning Letter to Jieying Laboratory, Inc. following an inspection from October 27-30, 2014, in Longueuil, Quebec, Canada. The inspection revealed that the firm's Class II assisted reproduction tools are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The letter details numerous violations, including:
1. **Failure to establish and maintain design control procedures** (21 CFR 820.30(a)), lacking requirements for design planning, input, output, review, verification, validation, transfer, changes, and design history files.
2. **Failure to validate processes** where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically for sterile micro-tool manufacturing and sterilization processes (e.g., lack of yearly bioburden/sterility recovery testing, revalidation for material changes).
3. **Failure to establish procedures for nonconforming product review and disposition** (21 CFR 820.90(b)(1)).
4. **Failure to develop, conduct, control, and monitor production processes** to ensure device conformity (2

## Related Officers

- [Jan B. Welch](https://www.keypedia.com/people/jan-b-welch/65bfaf7c-7ce6-4c33-80bd-090efbf2eec5)
- [Xiaomin Yu](https://www.keypedia.com/people/xiaomin-yu/d662ca7a-2e6f-4ec4-b5b9-549f6b0495dc)

Company: https://www.keypedia.com/companies/jieying-laboratory-inc/8b56fe16-898d-46be-b99d-0597e88a9efb

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7