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# Compounding Violations at Sewaren Innovative
- URL: https://www.fdaweb.com/compounding-violations-at-sewaren-innovative/
- Published: 2017-06-20T12:00:00.000Z
- Updated: 2026-09-14T22:30:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138978

A 4/18-6/28/16 FDA inspection at Sewaren Innovative Pharmaceutical Packaging, Avenel, NJ, found that the firm failed to meet conditions required for exemption from some drug compounding regulations. A 5/22 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm563170.htm?ref=fdaweb.com) from the agency’s New Jersey District Office says the investigator found that the firm: 

- has aseptic processing areas deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure;
- 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; and
- failed to establish a 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 says the company also produced misbranded drug products intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and for which adequate directions for use cannot be written such that a layperson could safely use the products for their intended uses.

FDA acknowledges the firm’s commitment to voluntarily cease sterile compounding activities following an inspection by the New Jersey Board of Pharmacy. It strongly recommends that if the firm decides to resume production of sterile drugs, its management undertake a comprehensive assessment of operations, including facility design, procedures, processes, maintenance materials, and systems, with a particular focus on aseptic processing operations. FDA says that a consultant with relevant sterile drug manufacturing experience could be useful.

Sewaren was told to respond with any steps the firm took to correct the violations or to indicate that it does not plan to resume producing sterile drugs.