Last Updated on April 16, 2025 by The Health Master
USFDA inspection
Aurobindo Pharma, a Hyderabad-based pharmaceutical giant, recently announced that U.S. Food and Drugs Administration inspection (USFDA inspection) has been concluded at its wholly-owned step-down subsidiary, Aurolife Pharma LLC, and received a Form 483 with 11 observations.
This USFDA inspection was conducted at Aurolife Pharma’s manufacturing plant located in Raleigh, North Carolina, USA.
The above-said facility is specialized in the manufacturing of dermatological products and inhalers.
The USFDA inspection was carried out from March 24th to April 10th, 2025 which observed various violations of the Food Drug and Cosmetic (FD&C) Act and its related regulations.
What is a Form 483
A Form 483 is a document having details of observations issued by the USFDA to a company after concluding an inspection.
It formally communicates to the company about the observations pointed out during the inspection.
These observations can vary from minor procedural oversights to more important deviations in manufacturing processes and quality control systems.
Aurobindo’s Commitment
The company defined these 11 observations as “procedural in nature,” regarding the documentation, adherence to laid-down regulations, or other operational issues rather than serious flaws in product quality or safety.
Aurobindo Pharma Limited is a well-established, integrated global pharmaceutical company with its headquarters situated in Hyderabad, India.
The company is involved in the entire pharmaceutical value chain, from the development and manufacturing of active pharmaceutical ingredients (APIs) to the production and commercialization of a broad spectrum of generic and branded specialty pharmaceutical formulations.
Q. What is a USFDA Form 483?
A. A Form 483 is an important document issued by the USFDA to a company after concluding an inspection. It formally communicates to the company about the observations pointed out during the inspection.
Q. What are “procedural” observations?
A. In this context, “procedural” observations likely refer to issues related to documentation, adherence to established protocols, record-keeping practices, or other operational aspects of the manufacturing process, rather than fundamental flaws in the quality or safety of the products themselves.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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