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.
Mumbai-based drug major Lupin’s regulatory woes don’t seem to be ending this year. After being issued two Form 483s by the US Food and Drug Administration to the Pune and Nagpur plants in October, a warning letter was also issued to the Tarapur facility recently. 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.
company said its working towards addressing the concerns raised by FDA, 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 post an inspection by USFDA from March 22 to April 4. ``We have clarified to FDA that we continue manufacture from the site from multiple manufacturing blocks in a compliant manner”, a company spokesperson told the media agency. The warning letter issued by 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 are 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 failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API. 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 API’’. Lupin scrip is down 21% so far this year, from Rs 944.55 to Rs 753.30 Tuesday, on the Bombay Stock Exchange. Regarding Nagpur, the USFDA inspected the injectable manufacturing unit from October 17 to 29. The inspection was a pre-approval inspection (PAI) and was closed with Form-483 with five observations