Last Updated on June 23, 2025 by The Health Master
USFDA inspection
Alembic Pharmaceuticals provides a progress report on a United States Food and Drug Administration inspection (USFDA inspection) of its Panelav API-I & II facility.
USFDA’s Form 483
Regulatory compliance is essential to the successful operation of pharmaceutical undertakings, especially in highly stringent and monitored issues within the US marketplace.
The USFDA’s Form 483 is an important document given to firm management at the conclusion of an inspection when the investigator observed any conditions that might constitute a violation of the Food, Drug, and Cosmetic Act (FD&C) and various related Acts.
According to the release by Alembic, the USFDA inspection has been concluded at Alembic Pharmaceuticals‘ Panelav Active Pharmaceutical Ingredient (API) facility, Panelav API-I and Panelav API-II, from May 26, 2025, through June 01, 2025.
At the conclusion of the nearly week-long investigation, a Form 483 was issued with four specific observations.
What are the Observations on Form 483
Upon issuance of a Form 483, there is usually undue panic; however, Alembic Pharmaceuticals reports via regulatory filing that none of the four observations are related to data integrity.
This is positive news relative to the determination of the USFDA over the last few years, in which many establishments find they are on hold with the USFDA for longer periods after observations relating to data integrity, as these are taken more seriously in terms of finding failures in compliance.
In addition, Alembic Pharmaceuticals management believes that these observations are “addressable,” which means that they are likely procedural or infrastructural/information-keeping related as opposed to a major failure in defect of product formulation or safety of the cGMP process.
Alembic Pharmaceuticals intends to respond to the USFDA relative to these observations within the designated time frame given post-Form 483 receipt, a customary expected response after receipt of such an important document.
Q. What is a USFDA Form 483?
A USFDA Form 483 is a document issued by the United States Food and Drug Administration to management at the conclusion of an inspection that details what was observed that may be a violation of the Food, Drug, and Cosmetic Act (FD&C) or related Acts.
Q. How often does the USFDA perform inspections?
The USFDA performs routine inspections that are announced and unannounced. There is no set frequency; it depends upon the establishment and its compliance history.
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