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# Multiple Violations in Aspire Pharma Inspection
- URL: https://www.fdaweb.com/multiple-violations-in-aspire-pharma-inspection/
- Published: 2023-04-05T12:00:00.000Z
- Updated: 2026-09-14T18:23:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154145

A 2001 and 2002 FDA inspection of the Aspire Pharmaceuticals dietary supplement and drug manufacturing facility in Somerset, NJ, identified significant violations of the Federal Food, Drug, and Cosmetic Act and its regulations. A just-released 11/22/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aspire-pharmaceuticals-inc-630328-11222022?ref=fdaweb.com) said specific violations were:

- failing to ensure that the dietary supplement tests or examinations used to determine whether specifications are met are appropriate, scientifically valid methods;
- failure of the firm’s quality control personnel to conduct a dietary supplement material review and make a disposition decision when an established specification was not met;
- dietary supplements are misbranded because they do not comply with dietary supplement labeling requirements;
- failing to ensure that human drug laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.

The letter says Aspire’s responses to the inspection observations were inadequate. “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” FDA says. The agency strongly recommends that Aspire retain a consultant highly qualified in data integrity assessment to assist in its remediation.

Aspire was told to respond with a list of specific actions it has taken to address any violations, with an explanation of each step taken to prevent the recurrence of violations, as well as copies of related documentation and a timetable for completing the corrections.