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# CP Pharmaceuticals Inspection Found CGMP Issues
- URL: https://www.fdaweb.com/cp-pharmaceuticals-inspection-found-cgmp-issues/
- Published: 2016-11-22T12:00:00.000Z
- Updated: 2026-09-14T21:49:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137401

A 10/5-10/13/15 FDA inspection at CP Pharmaceuticals, Wrexham, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm529931.htm?ref=fdaweb.com). Specific violations included: 

- failing to 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 such other control system necessary to prevent contamination or mix-ups in aseptic processing areas.

The letter says that based on the nature of the violations and the fact that some previous violations were not corrected, FDA strongly recommends that the company engage a qualified consultant to assist it in meeting CGMP requirements for aseptic processing. CP was told to provide a comprehensive evaluation of the design, control, maintenance, and oversight of its aseptic processing lines; a risk assessment of the potential effects of the observed deficiencies on the quality of its drug products; and an overall management strategy describing how the firm’s executive management will oversee improvements in operations and ensure ongoing oversight to provide for sustainable quality assurance. It also is to submit a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.