Dr. Reddy's Mexico USFDA Inspection Gets 2 Observations

Key Event Details

The United States Food and Drug Administration (USFDA) has completed a records assessment under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act at Dr. Reddy's API manufacturing facility, Industrias Químicas Falcón de México, S.A. de C.V. (Dr. Reddy's Mexico), located in Jiutepec, Morelos, Mexico.

Inspection Timeline

The assessment was conducted between July 17, 2026 and September 8, 2026.

Inspection Outcome

At the conclusion of the assessment, the USFDA issued a Form FDA 2953 containing two observations.

Company Response

The company will respond to the observations within the stipulated timeline provided by USFDA.

Disclosure Date

The disclosure was made on September 11, 2026, and signed by K Randhir Singh, Company Secretary, Compliance Officer & Head-CSR.

#Tags: #DrReddys #USFDA #Regulation30 #RegulatoryCompliance #Neutral