CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to ZIIP, Inc., 2026-05-22
Letter issued · posted to fda.gov .
Subject as published: CGMP/QSR/Medical Devices/Adulterated
TL;DR
At a glance: FDA's Center for Devices and Radiological Health issued a warning letter (CMS # 725870, May 22, 2026) to ZIIP, Inc. (Pleasant Hill, CA) following a January 5-12, 2026 inspection, citing adulteration of the ZIIP HALO, HALO 2.0, DOT, and Gels devices under 21 U.S.C. § 351(h) due to failure to comply with Quality System Regulation requirements (21 CFR Part 820). Violations include: incomplete design verification documentation lacking firmware build versions and raw data attachments; inadequate design validation and risk analysis procedures; and failure to incorporate complaint data (2022-2025 reports of smoking, burning, melting, and fire hazards) into hazard classifications that were rated "negligible" despite documented consumer injuries and property damage.
Argus analysis
# FDA Warning Letter Analysis: ZIIP, Inc.
**Company and Findings**
ZIIP, Inc., a medical device manufacturer in Pleasant Hill, California, received a warning letter from the FDA's Center for Devices and Radiological Health on May 22, 2026, following a January 2026 inspection. The agency determined that ZIIP manufactures the HALO and HALO 2.0 devices, along with the ZIIP DOT and ZIIP Gels, all classified as medical devices. FDA investigators found these products were adulterated because manufacturing methods, facilities, and controls failed to comply with current good manufacturing practice requirements.
**Regulatory Citations and Violations**
The warning letter cites 21 CFR Part 820, the Quality System Regulation (QSR). Specific violations include 21 CFR 820.30(f)—design verification requirements—and 21 CFR 820.30(g)—design validation and risk analysis requirements. The design verification violation centers on incomplete documentation: missing raw data files, undocumented firmware versions, and external testing reports lacking formal review approval. The design validation violation is more serious. ZIIP's risk management failed to incorporate complaint data showing multiple incidents of device overheating, smoking, and burning between 2022 and 2025—conditions the firm had classified as "negligible" severity despite customer reports of potential fire hazards and burned skin. Similarly, gel intrusion into charging ports was rated "remote" probability despite documented complaints since March 2024.
**Response Timeline and Industry Monitoring**
ZIIP provided responses to FDA observations in February and May 2026, but FDA found them inadequate. The firm committed to completing comprehensive verification protocols and revised hazard analyses by unspecified dates (redacted in the public record). Compliance officers should monitor whether ZIIP issues customer communications addressing overheating and fluid ingress risks before formal documentation updates conclude. Industry peers should note the agency's particular focus on complaint trending during post-market surveillance—firms must align documented risk classifications with actual field data regardless of testing timelines.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER ZIIP, Inc. MARCS-CMS 725870 — May 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Mr. David Mason Recipient Title General Manager ZIIP, Inc. 2495 Estand Way Pleasant Hill , CA 94523-3911 United States (b)(6), (b)(7)(C) Issuing Office: Center for Devices and Radiological Health United States WARNING LETTER CMS # 725870 May 22, 2026 Dear Mr. Mason: During an inspection of your firm located in Pleasant Hill, CA from January 5, 2026, through January 12, 2026, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ZIIP HALO device. Your website and other materials refer to both the HALO and the HALO 2.0. In addition, we have also reviewed your website at https://ziipbeauty.com and have determined that your firm markets the ZIIP DOT and the ZIIP Gels as well. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. Quality System Regulation Violations This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received responses from Marie Touriel, Quality Manager, dated February 3, 2026 and May 15, 2026, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address the responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to ensure that design verification confirmed that design outputs meet design input requirements, as required by 21 CFR 820.30(f). Specifically, a. Your firm's design control procedures, SOP-13, versions 2.0 and C, and SOP-14, Design Verification & Validation, established requirements for design verification from 03/21/2019 to 05/26/2025. Your firm documents design verification in design verification reports. The design verification report 199001-008: ZIIP 2.0 Verification Report states that it has raw data files and attachments, but these are not attached to the document and were not maintained by your firm. Additionally, the verification report references firmware testing without documenting the firmware build version. b. Your IEC 60601-1 testing report prepared by an external laboratory does not have evidence of formal review or approva…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has ZIIP, Inc. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for ZIIP, Inc. as of 2026-07-14. Argus ingests new FDA enforcement records daily.
- What FDA violations was ZIIP, Inc. cited for?
- The FDA Warning Letter to ZIIP, Inc. (issuing office: Center for Devices and Radiological Health) cites: CGMP/QSR/Medical Devices/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to ZIIP, Inc.?
- FDA issued the letter (MARCS-CMS 725870) on 2026-05-22 and posted it publicly on fda.gov on 2026-07-14.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to ZIIP, Inc., 2026-05-22. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ziip-inc-2026-05-22-cgmp
"CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to ZIIP, Inc., 2026-05-22." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ziip-inc-2026-05-22-cgmp.
Argus HQ Research. "CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to ZIIP, Inc., 2026-05-22." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ziip-inc-2026-05-22-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ziip_inc_2026_05_22_cgmp_2026,
title = {CGMP/QSR/Medical Devices/Adulterated: FDA Warning Letter to ZIIP, Inc., 2026-05-22},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ziip-inc-2026-05-22-cgmp},
note = {Accessed: July 15, 2026}
}