FDA Cites Ohom Padmaavathii, LLC in 2026-07-22 Warning Letter — Foreign Supplier Verification Program (FSVP)
Letter issued · posted to fda.gov .
Subject as published: Foreign Supplier Verification Program (FSVP)
TL;DR
The FDA issued a Warning Letter (CMS# 723534) to Ohom Padmaavathii, LLC on July 22, 2026, following a Foreign Supplier Verification Program (FSVP) inspection conducted December 2, 2025–January 6, 2026, citing failure to develop, maintain, and follow an FSVP for imported foods including flour from identified foreign suppliers, in violation of section 805 of the FD&C Act and 21 CFR part 1, subpart L. The company was directed to respond in writing within 15 working days with corrective actions and documentation, with notification that the FDA may refuse admission of imported foods or place them on detention without physical examination if violations are not adequately addressed.
Argus analysis
# FDA Warning Letter Analysis: Ohom Padmaavathii, LLC
**Company and Violations**
Ohom Padmaavathii, LLC, a food importer based in Dayton, New Jersey, received a warning letter from the FDA's Office of Inspections and Investigations on July 22, 2026, following an FSVP (Foreign Supplier Verification Program) inspection conducted December 2, 2025 through January 6, 2026. The agency documented that the company failed to develop and maintain required FSVP documentation for imported foods from identified foreign suppliers, including flour imports. This marks the company's fourth FDA inspection since 2020, suggesting a pattern of ongoing compliance concerns.
**Regulatory Citations and Requirements**
The violations center on 21 CFR Part 1, Subpart L, which implements Section 805 of the FD&C Act. This regulation requires food importers to establish written supplier verification programs based on identified food safety risks. The requirement mandates that importers evaluate their foreign suppliers' food safety practices, maintain documentation of that evaluation, and verify compliance with U.S. food safety standards before importing products. The absence of such a program—particularly for specific supplier relationships—constitutes a significant regulatory breach that exposes the imported food supply chain.
**Response Requirements and Industry Outlook**
Ohom Padmaavathii had 15 working days from letter receipt to submit a written response detailing corrective actions and supporting documentation. The company must address the specific violations or explain their position with supporting evidence. Peer compliance officers should note that failure to respond adequately may trigger detention without physical examination (DWPE) of incoming shipments under Import Alert #99-41, or FDA refusal of entry under Section 801(a)(3). The history of repeated inspections suggests FDA maintains heightened scrutiny of this importer's operations.
Severity context
Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
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 Ohom Padmaavathii, LLC MARCS-CMS 723534 — July 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Hetal Mehta Recipient Title Owner Ohom Padmaavathii, LLC 51 Liberty Dr. Dayton , NJ 08810-1613 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States July 22, 2026 WARNING LETTER RE: CMS# 723534 Dear Ms. Hetal Mehta: On December 02, 2025 to January 06, 2026, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of OHOM PADMAAVATHII LLC located at 51 Liberty Dr., Dayton, NJ 08810-1613. We also conducted an inspection on May 21, 2020, April 26, 2021, and April 27, 2022. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the implementing FSVP regulation in 21 CFR part 1, subpart L. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals. During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods from the foreign suppliers indicated in the attached list. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We have not received your response to the Form FDA 483a issued on January 06, 2026. Your significant violations of the FSVP regulation are as follows: You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for the foods you import from the foreign suppliers indicated in the attached list, including the following food: (b)(4) Flour, imported from (b)(4) , located in (b)(4) The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L. This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of…
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 FDA violations was Ohom Padmaavathii, LLC cited for?
- The FDA Warning Letter to Ohom Padmaavathii, LLC (issuing office: Office of Inspections and Investigations) cites: Foreign Supplier Verification Program (FSVP). Classification: Warning Letter.
- When did FDA issue the warning letter to Ohom Padmaavathii, LLC?
- FDA issued the letter (MARCS-CMS 723534) on 2026-07-22 and posted it publicly on fda.gov on 2026-09-22.
- Is the FDA warning letter to Ohom Padmaavathii, LLC publicly available?
- Yes. The full verbatim letter is published at fda.gov. Argus HQ links directly to the source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ohom-padmaavathii-llc-723534-07222026.
- What does a "low" severity rating mean for this letter?
- Low severity. Procedural or narrow scope; most peer companies resolve in the 15-business-day response window without structural change.
argus.hq
Don’t find out about the next one six weeks late.
Argus reads every FDA Warning Letter the day it publishes, summarizes it against your watchlist, and lands the ones touching your business in your inbox at 6am ET. Plans from $99/month. Cancel any time.
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). FDA Cites Ohom Padmaavathii, LLC in 2026-07-22 Warning Letter — Foreign Supplier Verification Program (FSVP). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-ohom-padmaavathii-llc-2026-07-22-warning-letter
"FDA Cites Ohom Padmaavathii, LLC in 2026-07-22 Warning Letter — Foreign Supplier Verification Program (FSVP)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-ohom-padmaavathii-llc-2026-07-22-warning-letter.
Argus HQ Research. "FDA Cites Ohom Padmaavathii, LLC in 2026-07-22 Warning Letter — Foreign Supplier Verification Program (FSVP)." Digital Empire Holdings LLC. Accessed September 25, 2026. https://argushq.ai/fda/warning-letter/fda-wl-ohom-padmaavathii-llc-2026-07-22-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_ohom_padmaavathii_llc_2026_07_22_warning_letter_2026,
title = {FDA Cites Ohom Padmaavathii, LLC in 2026-07-22 Warning Letter — Foreign Supplier Verification Program (FSVP)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-ohom-padmaavathii-llc-2026-07-22-warning-letter},
note = {Accessed: September 25, 2026}
}