What happened
Original notice title
Aspire Pharmaceuticals, Inc. MARCS-CMS 630328, November 22, 2022
From the archived source record
Based on our inspection and our. review of labeling collected during the inspection, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). We address your response below, in relation to each of the noted violations. Dietary Supplement cGMP Violations During the inspection, our investigators found significant violations of Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause the dietary supplements 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 the dietary supplements 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. This system includes testing for: Total aerobic plate count, procedure MICROSTP-001 Yeast and mold, procedure MICROSTP-002 Salmonella, procedure MICROSTP-003 Staphylococcus aureus, procedure MICROSTP-004 Escherichia coli, procedure MICROSTP-005 Enterobacteriaceae, procedure MICROSTP-006 However, you are not conducting suitability testing to demonstrate whether these methods are appropriate for testing all of your products. All microbiological testing is currently being sent out while improvements to the micro lab facility and procedures can be carried out to address the apparent contamination issues in the micro lab. (Status: Completed on time)." We are unable to evaluate the adequacy of your response because you did not provide documentation to support that you have made the proposed corrective actions. Misbranded Dietary Supplements In addition, your product (b)(4) , is a misbranded dietary supplement within the meaning of section 403 of the Act [21 U.S.C. § 343] because it does not comply with the labeling requirements for dietary supplements.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 8acddb5da379
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
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