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Pharma MSMEs get a shot in the arm with zero observations from US FDA
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Shardul Nautiyal, Mumbai
May 16 , 2023
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In a major boost to the domestic pharma industry, pharma MSMEs in Gujarat have got zero observation or Form 483 from the US FDA in the recent inspections done by the agency. This comes at a time when the Indian pharma industry has suffered a big blow to its image as the pharmacy of the world with reports of contaminated medicines exported by the Indian pharma firms.
The US FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
“With clearance in 483, these MSMEs are today qualified to compete in the global market just like the big pharma companies like Zydus Cadila. These companies have cleared the inspection with zero observation or defect,” informed Gujarat FDCA Commissioner Dr HG Koshia.
The FDA Form 483 is officially called a "Notice of Inspectional Observations," commonly referred to simply as a "483."
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice.
FDA Form 483 intended is not an all-inclusive list of every possible deviation from law and regulation. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.
The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report (EIR), all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
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