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# Mylan Inspection Yields 32-Page FDA-483
- URL: https://www.fdaweb.com/mylan-inspection-yields-32-page-fda-483/
- Published: 2018-06-28T12:00:00.000Z
- Updated: 2026-09-15T00:16:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141796

FDA has published a 32-page FDA-483 with 13 observations issued following a 3/19-4/12 inspection at the Mylan Pharmaceuticals finished drug manufacturing facility in Morgantown, WV. The specific inspection [observations](https://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM611933?ref=fdaweb.com) were: 

- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to clean, maintain, and sanitize equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failing to follow written procedures for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product;
- procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use;
- laboratory controls do not include establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to examine visually the reserve samples from representative sample lots of batches of drug products selected by acceptable statistical procedures at least once a year for evidence of deterioration;
- 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 follow written production and process controls in the execution of production and process control functions;
- failing to have written procedures drafted, reviewed, and approved by the appropriate organizational unit and reviewed and approved by the quality control unit;
- failing to establish time limits when appropriate for the completion of each production phase to assure the quality of the drug product;
- failing to thoroughly review any unexplained discrepancy and 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 have drug product production and control records reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed; and
- failing to have written records of investigation of a drug including the follow-up.