Recently, the USFDA had issued 10 Form 483 observations on the company’s Unit III, a formulation manufacturing facility located at Bachupally in Hyderabad.
Aurobindo Pharma has received a warning letter from the United States Food and Drug Administration (USFDA) for one of its units in Srikakulam district of Andhra Pradesh, inspected earlier this year. However, the company did not provide any details of contents of the warning letter.
“The company has received a warning letter from the USFDA relating to our unit XI, active pharmaceutical ingredient (API) manufacturing facility situated at Srikakulam district, Andhra Pradesh. This action follows the earlier inspection of the site by the USFDA in February 2019,’’ Aurobindo Pharma said in a BSE filing.
The company said it, “believes the existing business from this facility will not be impacted.”
“We will be engaging with the regulator and are fully-committed in resolving this issue at the earliest. The company is also committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe,” the company added. To date, the company is faced with USFDA compliance issues at four of its manufacturing sites. The company’s three facilities Unit I (Medak, Telangana), Unit XI (Pydibheemavaram, Andhra Pradesh), and intermediates facility of Unit IX (Medak, Telangana) were classified by USFDA as Official Action Indicated (OAI).
Recently, the USFDA had issued 10 Form 483 observations on the company’s Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad. The regulator had pointed out data integrity lapses at its finished dosages plant at Bachupally. The FDA issued Form 483 with 10 observations on the plant, which was audited by the US drug regulator between May 13 and May 24. These include laboratory records without complete data derived from all tests, examinations and assays necessary to assure compliance with established specifications and standards, the FDA had said.