Pharmaceutical major Dr Reddy’s Laboratories on Friday said the US health regulator has conducted a records assessment of its active pharmaceutical ingredient (API) manufacturing facility in Mexico and issued two observations.
The assessment at the facility — Industrias Químicas Falcon de México, SA de CV (Dr Reddy’s Laboratories Ltd) — has been completed by the United States Food and Drug Administration (USFDA), the company said in a regulatory filing.
The assessment was carried out between July 17 and September 8, the filing said, without sharing details of the observations made by the US health regulator.
A records assessment by the USFDA refers to a regulatory review where the agency requests and examines a manufacturing facility’s documentation and records to evaluate compliance.
“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,” Dr Reddy’s Laboratories said.