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# Multiple Inspection Issues at Auro Pharmacies
- URL: https://www.fdaweb.com/multiple-inspection-issues-at-auro-pharmacies/
- Published: 2018-10-23T12:00:00.000Z
- Updated: 2026-09-15T00:40:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142646

A 6/13-6/29/17 FDA inspection at Auro Pharmacies, a La Habra, CA, outsourcing facility, found that the drug products produced there failed to meet the conditions of Section 503B of the Federal Food, Drug, and Cosmetic Act necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the law. The inspection also revealed serious deficiencies in the company’s practices for producing sterile drug products, according to a 9/24 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm623811.htm?ref=fdaweb.com). Specific violations included: 

- · compounded drug products using bulk substances including zinc chloride, selenium, and L-carnitine that are not eligible for 503B exemptions because the bulk substances are not on the 503B bulks list;
- failed to submit an initial product report to FDA in 9/2016 identifying drug products that were compounded during the previous six-month period;
- failed to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas;
- failed 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;
- failed 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;
- failed to have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product;
- failed to clean and, where indicated by the nature of the drug, sterilize and process container closures to remove pyrogenic properties to assure that they are suitable for their intended use; and
- failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates.

The letter also says that Auro does not have any FDA-approved applications on file for drug products that it compounds and that it compounds products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Since the labeling of such products fails to contain adequate directions for their intended uses, they are misbranded.

FDA acknowledges receipt of the company’s responses to the FDA-483 issued following the inspection and cannot fully evaluate some of the corrective actions due to lack of adequate supporting documentation.

“FDA strongly recommends your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” the letter says. “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.”

Auro was told to respond with a list of specific steps taken to correct the violations, with documentation of each step and a timetable for completion.