American Pharma Mfg. Inc.

WARNING LETTER American Pharma Mfg. Inc. MARCS-CMS 728227 — August 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Dietary Supplements Recipient: Recipient Name Mr. Vishal D. Savalia Recipient Title Chief Operating Officer American Pharma Mfg. Inc. 1845 S. Vineyard Ave Ste 5 Ontario , CA 91761-7762 United States Issuing Office: Human Foods Program United States August 4, 2026 WARNING LETTER CMS #728227 Dear Mr. Savalia: The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 1845 S. Vineyard Ave, Ste 5, Ontario, CA, from March 16-27, 2026. Based on inspectional findings, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov. At the conclusion of the inspection on March 27, 2026, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated April 14 and 17, 2026, and we address your responses below. Adulterated Dietary Supplements The inspection of your facility from March 16-27, 2026, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Your significant violations of the CGMP requirements are as follows: 1. You failed to ensure that each person who is identified to perform quality control operations is qualified to do so, as required by 21 CFR 111.12(b). Specifically, neither your Operations Manager nor your Production Manager, who are performing the responsibilities of quality control, is qualified to do so, as neither is knowledgeable about the applicable requirements. We have reviewed your responses, dated April 14 and 17, 2026. Your responses fail to demonstrate that you have adequately addressed the violation. In your response, you identified an employee to lead your quality control unit; however, you provided no information demonstrating that this person is qualified. 2. You failed to meet sanitation requirements that apply to your physical plant and grounds, as required by 21 CFR 111.15. Specifically, during the inspection, our investigator observed the following: You failed to maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b). Specifically, the (b)(4) pipes (b)(4) had powder build up and residue different than the color from the product being run in the machines; and the (b)(4) rooms had unknown residue/buildup on the floors and walls. Additionally, the corners of your walls in the blending room have holes, and there were temporary patches in place made with (b)(4) and (b)(4) . At least (b)(4) corners were (b)(4) , and where (b)(4) was broken it revealed the damaged wall underneath. You failed to identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces, as required by 21 CFR 111.15(c)(3). During the walk-through on March 17, 2026, our investigator observed a can of (b)(4) stored under a table that was adjacent to the (b)(4) filling line. Containers of ingredients, in-process products, and finished products of (b)(4) , Lot (b)(4) , were held adjacent or in the same area. You failed to take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests, as required by 21 CFR 111.15(d)(2). Specifically, we observed a gap at least (b)(4) tall at the bottom of an exit door in your warehouse, which does not prevent entry by pests. You failed to establish plumbing in your physical plant that is of an adequate size and design and that is adequately installed and maintained to properly convey sewage and liquid disposable waste from your physical plant, as required by 21 CFR 111.15(f)(2). Specifically, your firm is currently not allowed to discharge wastewater and is storing all liquid waste in a container located in the (b)(4) room. Adjacent to the enclosed container is an uncovered container with a pump inside filled with liquid of (b)(4) . We noted the uncovered container, and its immediate surroundings, were not maintained in a sanitary manner, with apparent splash marks and other unidentifiable substances on and around containers and along the wall. The wastewater containers were a few feet away from the (b)(4) and (b)(4) ladders. We have reviewed your responses, dated April 14 and 17, 2026. Your responses fail to demonstrate that you have adequately addressed the violation. In your response, you state that you were going to ensure that all doors are sealed or fitted with pest-proof sweeps, that you have moved all cleaning agents to a designated location, and that you have moved the containers of liquid waste to a designated area. However, you have not provided any photos or documentation of evidence to confirm corrective action has taken place. 3. You failed to establish the following specifications, as required by 21 CFR 111.70: For components used in the manufacture of a dietary supplement, you did not establish identity specifications; specifications necessary to ensure the specifications for purity, strength, and composition of the dietary supplement are met; and limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b). For example, you failed to establish specifications for the identity or limits of contaminates for the components (b)(4) and (b)(4) used to manufacture the dietary supplement product (b)(4) . In addition, you failed to establish specifications for the identity or limits of contaminants for the components (b)(4) and (b)(4) used to manufacture the dietary supplement product (b)(4) . For each dietary supplement that you manufacture, you did not establish product specifications for the identity, purity, strength, and composition of the finished batches of the dietary supplement, and for limits on those types of contaminants that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). You have not established specifications for your (b)(4) and (b)(4) dietary supplement products. We have reviewed your responses, dated April 14 and 17, 2026. Your responses fail to demonstrate that you have adequately addressed the violation. In your response, you stated that you will establish component and dietary supplement specifications; however, you have not submitted any further evidence of this corrective action to date. 4. You failed to prepare a batch production record (BPR) every time you manufactured a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, during the inspection you were unable to provide our investigator with a batch production record for your packaging operations for your (b)(4) dietary supplement product, lot (b)(4) . Additionally, for other dietary supplements you failed to prepare a BPR that includes all information required under 21 CFR 111.260. For example, your batch production records for the (b)(4) (lot (b)(4) ) and (b)(4) (lot (b)(4) ) dietary supplement products that you manufacture failed to include: A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing (21 CFR 111.260(f)); Documentation, at the time of performance, of the manufacture of the batch (21 CFR 111.260(j)). We have reviewed your responses, dated April 14 and 17, 2026. Your responses fail to demonstrate that you have adequately addressed the violation. In your response, you stated that you retroactively created a BPR for the (b)(4) product and placed lot (b)(4) on hold pending full quality review and release. For other products you stated that you created new master BPR templates and were planning to implement an (b)(4) record system in (b)(4) . However, you have not provided any evidence of these corrective actions. 5. You failed to take all the necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements by failing to use effective measures to protect against the inclusion of metal or other foreign material in components or dietary supplements, as required by 21 CFR 111.365(i). Specifically, on March 16, 2026, your metal detector was not properly connected while filling and packaging a dietary supplement product. On March 17, 2026, our investigator observed the metal detector check failing to detect the metal test pieces. On March 23, 2026, our investigator observed that the employee using the metal detector was not performing the metal detector check properly and was not documenting the actual time of performance. We have reviewed your responses, dated April 14 and 17, 2026. Your responses fail to demonstrate that you have adequately addressed the violation. In your response, you state that you have recalibrated your metal detector. Calibrating your metal detector will not address the root causes of this violation in full. This letter is not intended to be an all-inclusive statement of violations that may exist 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 FDA regulations. This letter notifies you of our concerns and provides you 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 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 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Your written reply should be directed to Rebecca Allen, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #728227 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov. Sincerely, /S/ Maria S. Knirk, JD, MBA Director, Office of Enforcement Office of Compliance and Enforcement Human Foods Program Content current as of: 09/29/2026 Regulated Product(s) Dietary Supplements