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# Strides Pharma FDA-483
- URL: https://www.fdaweb.com/strides-pharma-fda-483/
- Published: 2018-09-27T12:00:00.000Z
- Updated: 2026-09-15T00:34:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142465

FDA has released the FDA-483 issued following an 8/20-8/24 inspection at Strides Pharma Science, Karnataka, India. The three inspection observations on the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621786.pdf?ref=fdaweb.com) were: 

- · written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment, and materials used and parameters relevant to the operation;
- · control procedures are not established that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product; and
- the specifications for components, drug product containers or closures and labeling are deficient in that they do not include a description of the testing to be performed.