Last Updated on December 30, 2023 by The Health Master
Mumbai: Mumbai-based drug major Lupin’s regulatory woes don’t seem to be ending this year. The US Food and Drug Administration (USFDA) issued:
- Form 483 to the Pune plant
- Form 483 to the Nagpur plants
- A warning letter was recently issued to the Tarapur facility.
The issuance of Form 483 implies that the USFDA found certain procedural lapses and has sought corrective action from the company.
The issuance of a warning letter – which is more serious–implies that the company cannot export drugs manufactured at the facility to the US.
The company said its working towards addressing the concerns raised by USFDA, and “believes this will not have an impact on disruption of supplies or the existing revenues from operations of this facility’’.
The warning letter to the Tarapur plant was issued after an inspection by the USFDA from March 22 to April 4.
“We have clarified to USFDA that we continue to manufacture from the site from multiple manufacturing blocks in a compliant manner”, a company spokesperson told the media agency.
The warning letter issued by the USFDA on September 27 summarizes significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)’’, the USFDA communication says.
It states there is a failure to establish adequate written procedures for cleaning equipment and its release for use in the manufacture of intermediates and APIs.
The letter mentions “a failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and APIs.”
Regarding Nagpur, the USFDA inspected the injectable manufacturing unit from October 17 to 29. The inspection was a pre-approval inspection (PAI), and it was completed with Form 483, which included five observations.
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