Last Updated on October 17, 2024 by The Health Master
USFDA Inspection
The U.S. Food and Drug Administration (USFDA) Identifies Procedural Lapses at Aurobindo Pharma’s Manufacturing Unit in Telangana
In a recent development, the USFDA has brought attention to three procedural lapses at Aurobindo Pharma Ltd.’s formulation manufacturing facility situated in Telangana.
The regulatory agency conducted a comprehensive inspection at the company’s Unit III, located in the Bachupally village of the Medchal Malkajgiri district in Telangana.
The inspection, which took place from July 14 to 21, resulted in the issuance of a Form 483, outlining three distinct observations.
Procedural lapses Highlighted by the USFDA
The observations noted by the USFDA during their inspection are centered around procedural aspects and have been indicated as procedural lapses.
Aurobindo Pharma addressed these observations in an official exchange filing made on July 21.
It’s worth noting that a Form 483 is typically issued when inspectors identify conditions that, in their expert assessment, could potentially breach the Food, Drug, and Cosmetic Act as well as associated regulations.
Obtaining the Observation Details
BQ Prime, a reliable source for financial and business news, has managed to acquire a copy of the observations made by the USFDA during their inspection.
These observations provide insight into the specific areas that require attention within Aurobindo Pharma’s manufacturing facility.
Detailed Observations
The USFDA inspection has identified three primary areas of concern within Aurobindo Pharma’s formulation manufacturing facility:
1. Inadequate Procedures for Equipment Cleaning and Maintenance:
The manufacturing facility lacks established written procedures for the cleaning and maintenance of equipment, including utensils that are employed in the manufacturing, processing, or storage of finished drug products.
2. Building Maintenance and Sanitation Issue:
The inspection has raised concerns about the cleanliness and sanitary condition of the manufacturing building.
Notably, the quality control laboratory’s ceiling was found to be leaking, with the leakage occurring near a pharmaceutical refrigerator responsible for storing chemicals used in analytical testing.
3. Laboratory Control Mechanism Discrepancy:
The established laboratory control mechanisms were not being followed as per the USFDA’s findings.
Specifically, the quality control laboratory was observed to possess testing apparatus with solid, dark-colored flakes present.
Response from Aurobindo Pharma and Ongoing Steps
Despite the observations, Aurobindo Pharma has not yet issued a response to queries sent via email regarding the inspection results.
The company has also refrained from commenting on the measures it plans to undertake in order to address the highlighted issues.
Furthermore, there is no information available concerning the expected timelines for resolving the concerns raised by the USFDA.
In conclusion, the USFDA’s recent inspection at Aurobindo Pharma’s formulation manufacturing facility in Telangana has brought to light several procedural lapses that warrant attention.
While the company has acknowledged these observations, there is still anticipation regarding their forthcoming response and the measures they plan to adopt to rectify the highlighted issues.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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