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# FDA Releases 27-Page Mylan FDA-483
- URL: https://www.fdaweb.com/fda-releases-27-page-mylan-fda-483/
- Published: 2026-10-22T19:32:35.000Z
- Updated: 2026-10-22T19:32:35.000Z
- Author: David McFarland
- Tags: Drugs

FDA has released the 27-page Form FDA-483 with six observations from a 5/4-5/15 inspection at the Mylan Laboratories drug manufacturing facility in Maharashtra, India. The [inspection observations](https://www.fda.gov/media/195241/download?ref=fdaweb.com) were:

- failure to fully follow the responsibilities and procedures applicable to the quality control unit;
- failure 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;
- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch had been already distributed;
- equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
- failure to follow the written stability testing program; and
- failure to submit a Field Alert Report within three days of receiving information concerning a failure of one or more distributed batches of a drug to meet the specifications established in the application.