Thursday, November 18, 2021

Recalls requested by regulatory agency

Recall is an action taken to withdraw/remove the drugs from distribution or use including corrective action for which deficiencies are reported in quality, efficacy or safety. The defective products related to quality includes Not of Standard Quality, Adulterated or Spurious drugs.

A recall occurs when a firm removes or corrects a marketed product that violates FDA-administered laws and regulations and would be subject to FDA legal action.

All food firms should have a recall plan in place, in order to act promptly and effectively in the event of a recall. Being prepared reduces the risk of potentially harmful or hazardous food from reaching consumers and potentially wreaking devastating effects on human health and the economy.

There are basically three types of recall policies
· Voluntary recalls
· Product seizures
· Recalls may be requested by the regulatory agencies due to the product being harmful, a risk to the public, or out of compliance with food regulations.

Firms may initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA.

FDA also has mandatory recall authority for a variety of products, including FDA-regulated devices, certain biological products and food.

A firm should promptly consult with technical experts and legal counsel if FDA requests or recommends a recall. It should also ask FDA questions in areas such as the scientific and public health basis for the recall; the scope of the recall (including areas of distribution, dates of manufacture and types of products).

FDA may take appropriate regulatory action or other measures when the firm fails to recall violative product or when a recall action fails.
Recalls requested by regulatory agency

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