IF Co-Pack, LLC dba Initiative Foods

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September 29, 2026

WARNING LETTER

Re: CMS # 732244

Dear Mr. Ephgrave:

The United States Food and Drug Administration (FDA) conducted an inspection of your ready-to-eat (RTE) food manufacturing facility, located at 1912 Industrial Way, Sanger, California from March 31 to April 9, 2026. Your firm manufactures high-acid, acidified, and low-acid canned (LACF) fruit and vegetable baby food products. The inspection revealed significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117).

The failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection, FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations, listing the violations observed at your facility. As of the date of this letter, we have not received a response to the FDA-483 issued to you at the close of the inspection on April 9, 2026. Based on our review of the inspectional findings, FDA is issuing this letter to advise you of our concerns and to provide detailed information describing the findings at your facility.

Your significant violations were as follows:

Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C)

1. You did not identify and evaluate known or reasonably foreseeable hazards to determine whether they required preventive controls, as required by 21 CFR 117.130(a)(1).

Specifically, your hazard analysis for your “Acidified/High Acid Fruit and Vegetable Products – Pouches” did not identify patulin as a hazard requiring a preventive control. Patulin is a mycotoxin produced by mold species commonly associated with apples and other fruits, and its presence in apple-containing products is a well-recognized food safety hazard. Your facility manufactures fruit puree baby food, such as (b)(4) baby food pouches containing apple ingredients. However, your “Hazard Analysis Risk Assessment” indicated patulin as having a low likelihood of occurrence in the absence of preventive controls in incoming (b)(4) ingredients.

Preventive controls, such as process controls and supply-chain controls, must be established as appropriate to your facility and your food (see 21 CFR 117.135(c)). Your facility has not established preventive controls like patulin specifications for your (b)(4) used to manufacture your baby food products. For example, your facility receives Certificates of Analysis (COAs) that include patulin levels for some incoming (b)(4) and (b)(4). However, there is no documentation demonstrating that these COAs are reviewed as part of preventive control measures to significantly minimize or prevent patulin in your baby food products (see 21 CFR 117.135(a)(1)). Additionally, on December 26, 2025, you used (b)(4), lot #(b)(4), to manufacture (b)(4) Baby Food Pouches, lot #(b)(4). The COA for this (b)(4) did not include patulin testing results, and there is no documentation indicating that your firm identified or addressed this deficiency prior to use of the ingredient in production.

The significance of patulin as a hazard in your operations is further demonstrated by your firm's February 2026 voluntary recall of "Tippy Toes" brand Apple Pear Banana puree due to elevated patulin levels. This recall was initiated after FDA notified your facility of analytical findings from FDA’s Total Diet Study (TDS)¹. A non-regulatory TDS sample of your product detected elevated patulin levels. Following FDA’s notification, your facility conducted internal testing of retained samples from lots your firm determined to be potentially related to the implicated TDS lot. This private lab testing detected patulin at a level of 40 ppb in one lot, prompting the voluntary recall.

The violations cited in this letter are not intended to be an all-inclusive list of the violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including applicable FDA regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and provide the time within which you will do so. If you believe your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Please send your reply to the Food and Drug Administration, Attention: Marco Esteves, Compliance Officer, via email at Marco.Esteves@fda.hhs.gov. If you have any questions regarding this letter, you may contact Marco Esteves, Compliance Officer, via email at Marco.Esteves@fda.hhs.gov. Please reference 732244 on any submissions and within the subject line of any emails to us.

Sincerely,
/S/

Maria S. Knirk, JD MBA
Director
Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program

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1 The TDS is an ongoing FDA program that monitors levels of nutrients and contaminants in foods eaten by people in the United States. As part of the TDS, FDA purchases foods from the same retail outlets that consumers use and prepares them as consumers typically would, providing realistic estimates of contaminant and nutrient levels in the U.S. diet.