# FDA 483 - Dr. Reddy's Laboratories New York, Inc. - March 03, 2021

Source: https://www.globalkeysolutions.net/records/483/dr-reddys-laboratories-new-york-inc/9888363b-7da5-4a3f-868b-b2cf2c425bf4

> FDA 483 for Dr. Reddy's Laboratories New York, Inc. on March 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dr. Reddy's Laboratories New York, Inc.
- Inspection Date: 2021-03-03
- Product Type: drugs
- Office Name: Office of Human and Animal Foods Operations - East
- Summary: An FDA inspection of Dr. Reddy's Laboratories New York, Inc. in Middleburgh, NY, an Active Pharmaceutical Ingredient (API) Manufacturer, revealed significant deficiencies in equipment cleaning procedures and batch record documentation. The firm failed to establish detailed cleaning procedures with measurable endpoints, lacked cleaning validation studies for major equipment, and did not properly record equipment identification in batch records. These issues indicate a lack of adequate controls over manufacturing processes.

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## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

Company: https://www.globalkeysolutions.net/companies/dr-reddys-laboratories-new-york-inc/0eed3dcf-9a65-422d-95f0-c7fe0ec7debd

Office: https://www.globalkeysolutions.net/offices/office-of-human-and-animal-foods-operations-east/f35344fc-4cf2-4605-b1cf-163d65050588