Last Updated on December 9, 2025 by The Health Master
USFDA inspection
The US Food and Drug Administration inspection (USFDA inspection) was carried out at one of Dr. Reddy’s Laboratories‘s formulation facilities in Andhra Pradesh.
It is especially good news for the Hyderabad drugmaker and those investors that keep their eyes on USFDA drug approval news, as well as pharmaceutical manufacturing compliance.
What’s the Timing of the Inspection?
The USFDA inspection occurred at the Srikakulam, Andhra Pradesh facility and was a Pre-Approval Inspection (PAI) conducted by the USFDA of the US.
A PAI is a common practice when plants request approvals for drug or formulation manufacture in the US.
There are certain timelines and details that come to light about such an inspection and how they culminate.
- Inspection Dates: July 10 through July 18.
- Inspection Results: Upon completion of the USFDA inspection, the US regulator, however, issued seven (7) observations from its findings under Form 483 (a form issued when a USFDA investigator has observed any conditions that may be violative under the Federal Food, Drug, and Cosmetic Act (FDCA) and related acts). The observations warrant further investigation due to their formal, detailed written nature.
What’s the VAI Status?
Ultimately, the most significant finding from this inspection came subsequently upon receipt of Dr. Reddy’s Establishment Inspection Report (EIR).
The EIR classified the inspection results as ‘Voluntary Action Indicated‘ (VAI) a relatively positive designation in the world of regulatory findings for quality assurance stakeholders in pharmaceutical quality.
Essentially, this means that although the USFDA found seven observations at the facility, they are not egregious enough to deny any pending product approvals from this facility and suggest that the company can and will fix these problems.
With closure on the EIR investigation under 21 CFR 20.64(d)(3), this means that anyone who’s following Dr. Reddy’s facility inspections can put their minds at ease for the time being, as this issue is closed out.
Q: What is a Pre-Approval Inspection (PAI)?
A PAI is an inspection conducted by the USFDA to determine whether a manufacturing facility is able and willing to comply with current Good Manufacturing Practices (cGMP) requirements before a new drug product made there can be approved for sale in the United States.
Q: Does a VAI classification mean the company is fully compliant?
A VAI (Voluntary Action Indicated) classification means that while there were some issues (the 7 observations), they are minor in nature. They do not preclude product approval and are expected to be voluntarily corrected by the company without any pressure from regulatory enforcement action. Therefore, it’s a good outcome for those who wish for a manageable level of compliance.
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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