Aurobindo Pharma Under U.S. FDA Scanner For Lapses At Telangana Facility
The drugs regulator conducted an inspection at the facility between July 14 and 21 and issued Form 483 with three observations.
The U.S. Food and Drug Administration has flagged three procedural lapses at Aurobindo Pharma Ltd.'s formulation manufacturing facility in Telangana.
The drugs regulator conducted an inspection at the company’s Unit III, formulation manufacturing facility in Bachupally village, Medchal Malkajgiri district, Telangana. The inspection took place between July 14 and 21 and resulted in the issuance of a Form 483, with three observations.
"The observations are procedural in nature," the company said in a July 21 exchange filing.
A Form 483 is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and Related Acts.
BQ Prime has obtained a copy of the observations from the administrator.
These are the observations that were made:
Written procedures are not established for the cleaning and maintenance of equipment, including utensils used in manufacturing, processing or holding finished drug product.
Building used in manufacturing not maintained in clean and sanitary condition. Specifically, ceiling of the quality control laboratory was leaking next to the pharma refrigerator used to store chemicals for analytical testing.
Established laboratory control mechanisms are not followed. In the quality control laboratory, testing apparatus was observed to have solid dark coloured flakes.
Queries emailed Aurobindo Pharma did not receive a response at the time of publishing this report. The company is also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.
Shares of the company were trading 1.59% lower at Rs 852.50 apiece, compared to a 0.43% fall in the benchmark Sensex at 12:30 p.m. on Friday.
