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# CGMP Problems at Porton Biopharma
- URL: https://www.fdaweb.com/cgmp-problems-at-porton-biopharma/
- Published: 2017-01-24T12:00:00.000Z
- Updated: 2026-09-14T22:02:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137802

A 3/7-3/18/16 FDA inspection at Porton Biopharma (formerly Public Health England), Salisbury, UK, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 1/19 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538105.htm?ref=fdaweb.com) says that specific violations and deviations included: 

- 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 been already distributed;
- failing to establish and follow appropriate written procedures designed to prevent microbiological contamination in drug products purporting to be sterile; and
- · failing to establish and follow change controls to evaluate all changes that could affect the production and control of intermediates or active pharmaceutical ingredients.

The letter says that similar CGMP violations were found in a 2015 inspection and that the firm proposed specific remediation for those violations at that time. “These repeated failures demonstrate that management oversight and control over the manufacture of drugs at your facility is inadequate,” it says, “and that your previous corrective actions did not address persistent contamination hazards and drug quality issues.”

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