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# CGMP, Other Violations at Leiter’s Compounding
- URL: https://www.fdaweb.com/cgmp-other-violations-at-leiters-compounding/
- Published: 2016-03-29T12:00:00.000Z
- Updated: 2026-09-14T20:51:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135207

> A 9/15-10/7/14 FDA inspection at Leiter’s Compounding, San Jose, CA, found current good manufacturing practice and other violations in the firm’s work as an outsourcing facility and determined that the company is producing drugs that violate the Federal Food, Drug, and Cosmetic Act, according to a just-released [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm492204.htm?ref=fdaweb.com) from the agency’s San Francisco District Office. Violations cited in the letter included:  
> failing to include the statement “this is a compounded drug” on labeling of any of the products compounded at the facility with the date the drug was compounded; failing to submit a report to FDA upon initial registration and again in 6/2014 identifying the drug products that were compounded during the previous six-month period; failing 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; failing to clean and, where indicated by the nature of the drug, sterilize and process container closures to remove pyrogenic properties to assure they are suitable for their intended use; failing 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; failing to establish time limits for the completion of each phase of production to assure drug product quality; 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; failing to have FDA-approved applications on file for its drug products; and compounding drugs that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners such that their labeling fails to contain adequate directions for their intended use.

The letter says that some of the corrective actions proposed by the company appear to be adequate, while others are deficient. “FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, 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 could be useful in conducting this comprehensive evaluation. You should fully implement necessary corrections in order to ensure that the drug product(s) produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.”

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