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# Bershtel Enterprises CGMP Violations
- URL: https://www.fdaweb.com/bershtel-enterprises-cgmp-violations/
- Published: 2019-05-14T12:00:00.000Z
- Updated: 2026-09-15T01:26:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144104

A 10/15-11/1/18 FDA inspection at Bershtel Enterprises, Duarte, CA, found violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 5/2 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bershtel-enterprises-llc-dba-wepackitall-570885-05022019?ref=fdaweb.com) says specific inspection observations were: 

- 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, and failing to perform operations within specifically defined areas of adequate size and to have separate or defined areas or other such control systems necessary to prevent contamination or mix-ups in aseptic processing areas;
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch of any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- failing to maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures.

The letter says FDA analyzed finished drug product samples collected at the facility and found that multiple lots of collected ophthalmic drug product were contaminated with *Bacillus spp*., high levels of particulate matter, or both. It also says Bershtel produces drugs under contract for customers and reminds the company that it is responsible for the quality of drugs it produces as a contractor regardless of any agreement in place with product owners.

FDA strongly recommends that the company retain a qualified third-party consultant to assist it in meeting CGMP requirements and help it identify drugs that are required to be sterile so it can meet its commitment to cease filling ophthalmic drugs or other sterile drugs.

Bershtel was told to respond with a list of actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for implementation.