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# CGMP Violations at Egypt’s Pharmaplast
- URL: https://www.fdaweb.com/cgmp-violations-at-egypts-pharmaplast/
- Published: 2023-04-25T12:00:00.000Z
- Updated: 2026-09-14T18:27:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154288

An 11/6-11/10/22 FDA inspection at the Pharmaplast drug manufacturing facility in Alexandria, Egypt, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pharmaplast-sae-648883-04132023?ref=fdaweb.com) says the specific violations were:

- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals; and
- failing to establish and follow adequate written procedures for cleaning and maintaining equipment.

The letter says the firm manufactures drugs that contain glycerin and ethanol. It says that glycerin contaminated with diethylene glycol and ethanol contaminated with methanol have resulted in lethal poisoning incidents in humans worldwide.

FDA placed Pharmaplast on an import alert on 4/4/23\. The company was told to correct any violations promptly and to respond with a list of specific actions it has taken to address any violations and prevent their recurrence, with a schedule for completing the corrections.