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# Dr. Reddy’s Hit With Form-483 After API Inspection
- URL: https://www.fdaweb.com/dr-reddys-hit-with-form-483-after-api-inspection/
- Published: 2021-03-10T12:00:00.000Z
- Updated: 2026-09-14T16:50:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148855

A recent inspection at Dr. Reddy’s Laboratories’ active pharmaceutical ingredient (API) manufacturing plant in Middleburg, NY cited three observations on a Form FDA-483\. The company says it will address the undisclosed findings within the agency’s stipulated timeline. “Currently, we do not have any sales from this plant,” Dr. Reddy’s said.

Before the Covid-19 emergency, Dr. Reddy’s was routinely inspected at various facilities. For example, FDA issued a 3/5/2020 [FDA 483](https://www.fda.gov/media/136641/download?ref=fdaweb.com) citing an inspection at a Telangana, India API facility. According to the 483, FDA found the facility’s system for reprocessing APIs and API intermediates to be insufficient. For example, the agency said that the company does not adequately identify reprocessed batches with a unique material number. It also did not adequately place API reprocessing process validation and commercially reprocessed lots on appropriate stability monitoring to demonstrate continued process capability throughout the lifecycle of the validated procedure. Additionally, retest periods for reference standards used in the quality control laboratory for analysis of APIs and API intermediates were not established with supporting analytical data.

Another FDA-483 was issued following a 1/20-1/28 inspection at the Dr. Reddy’s API manufacturing facility in Srikakulam District, Andhra Pradesh, India. The five observations on the [form](https://www.fda.gov/media/134938/download?ref=fdaweb.com) were: 

- failing to adequately perform process validation for manufactured products at the facility;
- investigations are inadequate in that they do not evaluate all potential root causes;
- failing to adequately establish and validate cleaning processes for equipment;
- failing to conduct trend analysis of manufactured APIs; and
- the quality unit lacks oversight of quality documents.