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# 6 Mylan Inspection Observations
- URL: https://www.fdaweb.com/6-mylan-inspection-observations/
- Published: 2018-06-26T12:00:00.000Z
- Updated: 2026-09-15T00:15:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141773

FDA has just released the FDA-483 containing six observations from a 9/5-9/14/16 inspection at Mylan’s finished drug manufacturing facility in Maharashtra, India. The specific [observations](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM611832.pdf?ref=fdaweb.com) were: 

- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods;
- failing to thoroughly review the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to have electronic records for the production and process control system comply with the electronic records requirements;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- failing to have written records of investigations of a drug complaint to include the findings of the investigation and follow-up; and
- failing to clean and maintain equipment and utensils at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.