USFDA Issues Two Observations After Records Assessment of Dr. Reddy's Mexico API Facility
New Delhi: Dr. Reddy's Laboratories Limited has informed that the US Food and Drug Administration (USFDA) completed a records assessment of its active pharmaceutical ingredient (API) manufacturing facility in Jiutepec, Morelos, Mexico, and issued two observations.
The assessment of Industrias Químicas Falcón de México, S.A. de C.V., also known as Dr. Reddy’s Mexico, was conducted under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act between July 17 and September 8, 2026.
At its conclusion, the USFDA issued a Form FDA 2953 containing two observations. The company said it would respond within the stipulated timeline.
The company stated, "At the conclusion of the assessment, the USFDA issued a Form FDA 2953 containing two observations, to which we will respond within the stipulated timeline."
Next Story