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# Multiple Violations at Acrx Specialty Pharmacy
- URL: https://www.fdaweb.com/multiple-violations-at-acrx-specialty-pharmacy/
- Published: 2020-08-04T12:00:00.000Z
- Updated: 2026-09-14T16:23:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147345

A 2/25-3/20/19 FDA inspection at Acrx Specialty Pharmacy, Las Vegas, NV, found multiple violations of drug compounding and other provisions of the Federal Food, Drug, and Cosmetic Act in the production of finished drugs. A 7/24 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acrx-specialty-pharmacy-inc-609518-07242020?ref=fdaweb.com) says Acrx failed to meet requirements for compounding human drug products, including failing to have valid prescriptions for individually identified patients for some of its drugs.

The letter also says Acrx produced adulterated drug products intended or expected to be sterile that instead were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

Violations of current good manufacturing practice regulations detailed in the letter were: 

- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
- failing to establish an adequate system for maintaining equipment used to control the aseptic conditions;
- failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates;
- failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit;
- failing to conduct laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements;
- failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release; and
- failing to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms.

FDA says the firm’s drugs also were misbranded because their labeling failed to bear adequate directions for their intended uses.

The agency reviewed the firm’s responses to the FDA-483 that was issued and says some of Acrx’ responses related to the insanitary condition observations appeared to be adequate, while the adequacy of some of the other responses could not be fully evaluated

The letter says that FDA recommends that Acrx management “undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.”

Acrx was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with related documentation and a timetable for completing the actions.