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Alembic Pharma under Pressure as USFDA Issues Form 483 to Gujarat Plant

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Alembic Pharma share price fell over 4 percent in intraday trade on December 16 following reports that the US Food and Drug Administration (USFDA) issued a Form 483 to the company’s Karkahadi plant in Gujarat.

US Food and Drug Administration (USFDA) issued a Form 483 for Alembic Pharma’s Karkahadi plant in Gujarat.

10 observations on Form 483 issued by the US regulator after its inspection at Alembic Pharma from October 28-November 10.

The regulator largely observed that the plant had not established control procedures and processes with respect to cleaning and maintenance were inadequate.

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 Alembic Pharma under Pressure as USFDA  Issues Form 483 to Gujarat Plant

The USFDA also said the procedures to prevent microbiological contamination were inadequate and that the plant did not maintain written records of investigations into unexplained discrepancies.

This Alembic Pharma facility is fairly new and has 10 injectable filings currently.

Analysts believe there are chances of escalation by the USFDA since one of the observations was repeated by the regulator.

Form FDA 483

The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) “Factory Inspection”.  Form FDA 483,  “Inspectional Observations,” is a form used by the FDA to document and communicate concerns discovered during these inspections. Also referred to as “Form 483” or merely “483”,  it states thereon that it

“… lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”

A recipient of a 483 should respond to the FDA, addressing each item, indicating agreement and either providing a timeline for correction or requesting clarification of what the FDA requires. This response must be submitted within 15 business days regardless of the number of observations, as of September 2009. While a response is not compulsory, a good response can usually help a company avoid receiving a Warning Letter from the FDA, withholding of product approval, or plant shut-down. Most experts warn that responses should be comprehensive, well-reasoned, well-documented and timely, and that each observation should be addressed individually.

The FDA encourages resolution of issues through informal mechanisms prior to the issuance of a 483. After issuance, manufacturers can use a formal two-tiered dispute resolution process described in the FDA document Guidance for Industry – Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP, and they have 30 calendar days to do so.

The FDA refers to cellular and tissue-based products as “human cells, tissue (biology), and cellular or tissue-based products” (HCT/Ps). To protect the health of consumers, the agency also inspects these facilities and documents observations on a 483. The authority to do so is granted by 21 CFR 1271 Subpart F.

The U.S. FDA has jurisdiction only within the United States. However, the supply chain for pharmaceuticals often extends far beyond the boundaries of the U.S., so the agency has an interest in assuring that foreign operations part of the U.S. supply chain are in an appropriate state of control, even though they have no legal authority to do so — although they can restrict importation into the U.S. The agency therefore performs foreign inspections, and observations for these are also captured on a 483. Regardless of the local language, the 483 will be written in English.

When is an FDA Form 483 issued?

A: 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.

What is the purpose of an FDA Form 483?

A: The 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.


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