Aspire Pharmaceuticals, Inc.
FDA issued a warning letter to Aspire Pharmaceuticals, Inc. (Somerset, NJ) following a joint inspection of their dietary supplement and drug manufacturing facility in late 2021 and early 2022. The agency found significant cGMP violations including use of scientifically invalid testing methods, failure to conduct material reviews for out-of-specification results, data integrity breaches (including an analyst who falsified sample weights to pass release specifications), and inadequate OOS investigation practices for both dietary supplement and drug products. The letter also cited misbranding of a dietary supplement due to an incorrect serving size declaration. FDA warned that failure to adequately address these violations may result in seizure and injunction.
Flagged claims (3)
Your (b)(4) Softgels Supplement Facts label declares "(b)(4)" but only lists one ingredient, that being (b)(4) fruit. We note a proprietary blend refers to more than one ingredient.
the product's label declares serving size as 2. The directions state to take two (2) softgels daily divided between morning and evening, with food, or as recommended by a healthcare practitioner. Serving size should be one based on one softgel per eating occasion.
Your "(b)(4)" product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect.
Required actions (5)
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.
provide a comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
provide a retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis
We strongly recommend that you retain a consultant highly qualified in data integrity assessment to assist in your remediation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most nutrition / supplements sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker