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# Multiple Violations Found in CP Pharmaceuticals Inspection
- URL: https://www.fdaweb.com/multiple-violations-found-in-cp-pharmaceuticals-inspection/
- Published: 2017-02-01T12:00:00.000Z
- Updated: 2026-09-14T22:04:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137885

FDA has released the FDA-483 from a 10/5-10/23/15 inspection at CP Pharmaceuticals, Wrexham, UK. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM538605.pdf?ref=fdaweb.com) lists these observations: 

- failing to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to follow procedures describing handling of all written and oral complaints about a drug product (repeat observation);
- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to provide adequate training required to perform assigned functions to employees engaged in the processing of a drug product;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing to use equipment of appropriate design to facilitate operations for its intended use in the manufacture, processing, packing, or holding of drug products;
- · failing to have laboratory controls include establishment of scientifically sound and appropriate specifications designed to assure that components, drug product containers, and closures conform to appropriate standards of identity, strength, quality, and purity;
- failing to take representative samples of each list of components, drug product containers, and closures for testing or examination;
- failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to have a written testing program designed to assess the stability characteristics of drug products;
- failing to establish written procedures for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected; and
- failing to visually examine reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures at least annually for evidence of deterioration.