Last Updated on June 1, 2025 by The Health Master
USFDA inspection
In May 2025, the United States Food and Drug Administration inspection (USFDA inspection) was conducted for five days at the Dr. Reddy’s Laboratories Middleburgh, New York, manufacturing site.
This occurrence of this USFDA inspection procurement was not out of the ordinary; it related to Good Manufacturing Practices (GMP) for drug creation and was a standard FDA check of its requirements.
USFDA Issues Form 483 to Dr. Reddy’s
At the conclusion of the USFDA inspection, a Form 483 was issued to the management of Dr. Reddy’s Laboratories.
A Form 483 is the official notification to management that an investigator observed something that may be a deviation from the Federal Food, Drug, and Cosmetic Act, and related regulations as applied to the observation.
Essentially, where there may be smoke, there could be fire—and herein lie the issues that the company needs to address.
Therefore, two observations made in the five days of review were important enough to warrant issuance in writing.
Dr. Reddy’s will Respond
Dr. Reddy’s Laboratories wants all stakeholders to know that they’re aware of the two observations post-Form 483 and that they are in a position to respond accordingly.
The company’s headquarters in India wants all stakeholders to know that compliance and quality are of utmost importance, and therefore, the response will acknowledge that Dr. Reddy’s is dedicated to compliance and quality.
They can assure all stakeholders that a thorough review will take place relative to the USFDA’s concerns with Dr. Reddy’s and that any corrective and preventive actions (CAPA) will be implemented as needed.
In addition, compliance implies that Dr. Reddy’s response will be in accordance with the timeframe given by the USFDA upon issuance of Form 483.
Q. What is a Form 483?
A Form 483 is an observations document issued by the USFDA to management upon conclusion of an inspection when an investigator has observed any conditions that may be violations of the Food, Drug, and Cosmetic (FD&C) Act and related acts.
Q. Is a Form 483 serious?
A Form 483 is not as serious as a warning letter; however, if any observation is made by an investigator during an inspection, it is recommended that it be taken seriously. A warning letter would follow an entity not responding appropriately to a Form 483 request or failing to comply with suggestions given within the Form 483.
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.
USFDA inspection: At Zydus with 6 observations
USFDA issues EIR for Emcure Pharma for Pune facility
USFDA inspection: At Aurobindo Pharma subsidiary with 11 observations
USFDA inspection: At Alembic with zero observations
Fake drugs worth Rs. 30 Crore seized in Uttar Pradesh
Include name of Authorised Person for Batch Release: DTAB
DCA Telangana: Special drive at Medical Stores for QR codes on 300 brands
Irrational Antibiotic combinations: Stricter Regulations
DTAB recommends ban on 34 antimicrobials for animal use
USFDA approval granted for Raltegravir Tablets
USFDA issues EIR to Piramal Pharma for Turbhe facility
DTAB recommends Ban on 16 Fixed Dose Combinations
Ranitidine Under Scrutiny: NDMA Levels & Shelf Life in Focus
