Quality Commitment — Kingphar
Quality Commitment

Transparency is
our standard

In 2025, our facility underwent an FDA inspection. We welcomed the process, addressed every observation, and used it as an opportunity to raise our quality standards beyond what was required.

What happened & what we did

June 30 – July 3, 2025
FDA facility inspection conducted
An FDA investigator from the Center for Devices and Radiological Health (CDRH) conducted a routine on-site inspection of our Qianjiang manufacturing facility.
October 3, 2025
Warning Letter received (CMS #716715)
FDA issued a Warning Letter citing observations related to environmental monitoring procedures in our ISO 8 cleanrooms and QC documentation practices. We responded within the required 15-business-day window with a full corrective action plan.
Q4 2025 – Q1 2026
All corrective actions fully implemented
Every observation cited in the Warning Letter has been addressed and implemented. We also voluntarily extended remediation to areas beyond the scope of the inspection.
Pending
FDA re-inspection & close-out
We are awaiting FDA's formal re-inspection to verify our corrective actions and issue the close-out letter. This page will be updated upon confirmation.
Corrective actions taken
All observations cited by FDA have been fully remediated. Below is a summary of the key measures implemented.

Cleanroom particle limit validation

Established validated alert and warning limits for viable and non-viable particle counts per ISO 14644-2 across all ISO 8 environments.

SOP redesign with breach protocols

Environmental monitoring SOPs redesigned to include clear excursion handling, investigation triggers, and defined response workflows.

CAPA system strengthening

Corrective and Preventive Action documentation upgraded for full traceability of QC decisions, root cause analysis, and closure verification.

Retrospective data review

Full retrospective review of all historical environmental monitoring data completed and analyzed against newly established control limits.

GMP documentation training

Comprehensive staff retraining on GMP documentation requirements, record integrity, and quality system responsibilities.

Internal audit frequency increased

Internal quality audit schedule upgraded beyond minimum regulatory requirement, with expanded scope across all production lines.

Beyond compliance — what we did voluntarily

The FDA inspection covered specific observations in our cleanroom monitoring and QC documentation. We used the process as an opportunity to conduct a full self-assessment of our entire quality management system — including areas not cited in the inspection — and implemented enhanced monitoring protocols, tightened internal control standards, and restructured our quality review cadence across the facility.

Current status: All corrective actions implemented. Awaiting FDA re-inspection and formal close-out confirmation. This page will be updated when the close-out letter is issued.
CMS #716715
View our certificates
ISO, CE, FDA documentation
Request audit documentation
Corrective action records available
Frequently asked questions
Questions we hear from procurement teams and distributors.

FDA does not issue blanket "approvals" to manufacturers — it regulates specific products and inspects facilities for compliance with Quality System Regulations (QSR). Kingphar holds 510(k) clearance for applicable products and has been registered with FDA as a device manufacturer. Our facility underwent FDA inspection in 2025, and all identified observations have since been fully remediated. We are awaiting FDA's formal re-inspection to close out the Warning Letter (CMS #716715).

In October 2025, FDA issued Warning Letter CMS #716715 following a facility inspection in June–July 2025. The observations cited related to environmental monitoring procedures in our ISO 8 cleanrooms and QC documentation practices. We responded within the required 15-business-day window with a comprehensive corrective action plan, and all remediation has since been fully implemented. A full summary of our corrective actions is available on this page. The Warning Letter remains publicly accessible at fda.gov.

Yes. An FDA Warning Letter is a compliance notification — it does not constitute a product recall, import ban, or suspension of manufacturing operations. Our facility continues to operate, and all corrective actions cited in the Warning Letter have been fully implemented. Buyers requiring documentation of our corrective actions or updated QC records are welcome to contact us directly.

Yes. Kingphar holds CE marking for applicable product categories including medical gauze, bandages, wound dressings, and first aid kits. CE certification is maintained under ISO 13485 quality management system requirements. Full certification documentation is available on our certificates page, and copies can be requested for specific products via our contact form.

Yes. We support buyer-initiated factory audits and can provide documentation including ISO 13485 certificates, cleanroom qualification reports, QC testing records, and a summary of our 2025 FDA corrective action implementation. For large-volume or tender procurement, we also offer video factory tours. Please contact us to arrange.

FDA's close-out process typically takes 12–18 months from the date of the Warning Letter, as it requires a formal re-inspection to verify that all corrective actions have been sustained. As of March 2026, no Warning Letters issued in 2025 have yet received close-out letters — this is consistent with FDA's standard process timeline, not indicative of unresolved issues. We will publish the close-out confirmation on this page as soon as it is received.

FDA Warning Letter CMS #716715 is publicly accessible at fda.gov. Issued October 3, 2025 · Kingphar Medical, Qianjiang, China