Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

LABELING RECALL FOLLOW-UP BY FDA TO INCLUDE FULL INSPECTION

Executive Summary

LABELING RECALL FOLLOW-UP BY FDA TO INCLUDE FULL INSPECTION of the recaller's label control operations, according to guidance to the field recently issued by FDA Office of Compliance Director Daniel Michels. "Follow-up inspections of all incidents such as recalls should not be limited to a determiantion that the recall is being adequately handled, but should also include a thorough inspection of the firm's basic controls to determine the underlying cause of the problem, where possible," Michels stated. The compliance office instructions call for particular emphasis to be placed on GMP labeling controls during inspections of newly registered drug repackagers or manufacturers. During these inspections, the guidance states, "the general level of competency of employees in these firms should be evaluated as well as the firm's training program for new employees." Special attention should be given to "unit-of-use" repackagers, the instructions state. The inspectional guidance is one of several steps recently taken by FDA to improve labeling control practices. Agency concern has been heightened by the fact that six labeling recalls over the last year have been given a Class I, or "potentially life threatening" designation. A letter also went out recently from Commissioner Young to the major drug industry associations asking for cooperation with FDA in encouraging adherence to current good manufacturing practices (CGMPS) for label controls and use of better technology ("The Pink Sheet" Jan. 18, p. 2). FDA is also working on revising the CGMP regulations to minimize problem practices and encourage the upgrading of controls. In conducting routine inspections, the compliance office guidance calls for inspectors to pay particular attention to label control procedures that have been previously associated with recalls ("The Pink Sheet" Oct. 19, T&G-10). For example, firms using cut labels that are similar in appearance without some type of 100% electronic verification system for the finished product "should be considered [to have] inadequate control over the labeling operation," the FDA directive states. Firms using outside contractors to print labeling, the guidance states, should have detailed information as to how the printer controls the printing process. "An audit of the printer should be performed by the firm on a regular basis and the drug firm must adequately examine the labeling upon receipt from the printer," the guidance notes. Two other categories of firms that should receive close investigational scrutiny, according to the compliance directive, are those which package products under a number of private labels, and those who have had multiple mislabeling recalls in the past few years. The districts are encouraged by FDA headquarters to pursue regulatory follow-up when GMP deviations regarding packaging and labeling controls are found. "Districts should consider issuance of an NAFL [Notice of Adverse Findings Letter] as a minimum," the directive states. "If significant deviations are noted at a recalling firm," the guidance adds, "the Center will be willing to consider additional regulatory action, especially if the firm has had multiple label recalls."
Advertisement
Advertisement
UsernamePublicRestriction

Register

PS013146

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel