Last Updated on March 7, 2025 by The Health Master
Warning letter
The US Food and Drug Administration (USFDA) has recently issued a warning letter to Jagsonpal Pharmaceuticals, raising concerns about their manufacturing practices.
The warning letter points to deviations from Current Good Manufacturing Practice (CGMP) standards at their plant situted in Bhiwadi, Rajasthan for the manufacturing of active pharmaceutical ingredient (API).
Concern Raised During Inspection
A USFDA inspection has been conducted between March 20th and April 3rd, 2024 which uncovered several issues deviating from the CGMP.
These practices are crucial to ensuring the safety, efficacy, and consistent quality of pharmaceutical products.
The warning letter details how Jagsonpal’s manufacturing methods, facilities, and controls fell short of these crucial standards.
Quality Control Systems
A major point of concern comes out during the USFDA inspection is that the apparent weakness of Jagsonpal’s quality systems.
The USFDA specifically called out the failure of the company’s quality unit to effectively ensure CGMP compliance at the contract manufacturing facility.
This lapse in oversight suggests deeper, systemic problems within Jagsonpal’s internal controls and quality assurance processes.
The USFDA’s warning letter emphasizes that drug manufacturers are ultimately responsible for the quality of their drug manufactured by them, regardless of any agreements they have with contract facilities.
This makes it clear that Jagsonpal is responsible for the manufacturing issues at their Bhiwadi plant.
Allegations of Obstruction and Limited Access
The situation is further complicated by allegations that USFDA inspectors were initially denied entry to the Bhiwadi facility on March 15th, 2024.
While inspectors were eventually granted access on March 20th, the agency reports that they faced limitations in accessing requested documents during the inspection.
The USFDA’s warning letter states that “when an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated.”
This alleged obstruction of the inspection process adds another layer of concern and raises significant questions about Jagsonpal’s transparency and cooperation with regulatory authorities.
What’s Next for Jagsonpal?
The USFDA has made it clear that Jagsonpal has to take immediate and thorough corrective action to address the identified issues.
They have recommended that Jagsonpal bring in a qualified consultant to assess their operations and help them fully CGMP compliance.
Until these issues are resolved and compliance is confirmed, the USFDA may choose to withhold approval for new drug applications or supplements that list Jagsonpal as a manufacturer.
A follow-up inspection is also likely to occur to verify that the corrective measures are effective.
Jagsonpal has 15 working days to provide a written response to the warning letter, outlining the steps they are taking to rectify the violations and prevent them from happening again.
A Wake-Up Call for the Industry
This warning letter serves as an important reminder of just how crucial CGMP compliance is within the pharmaceutical industry.
Manufacturing errors can have serious and potentially dangerous consequences for patients, leading to the distribution of substandard or even harmful medications.
What are APIs?
Active Pharmaceutical Ingredients (APIs) are the key components of a drug that produce the intended therapeutic effect.
What is CGMP?
Current Good Manufacturing Practice (CGMP) is a system of processes, procedures, and documentation that ensures drugs are consistently manufactured and controlled to meet all required quality standards.
What is a USFDA warning letter?
A warning letter is issued by the USFDA when a company is found to have significantly violated regulations, such as CGMP. It informs the company of the violations and requires them to take corrective action.
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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