What Form 483 means

June 26, 2008

After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit.

To provide the facility with its own written list of discrepancies noted during the inspection, FDA developed form FDA 483, “Notice of Inspectional Observations,” issued by the field investigator.

Form 483 should contain only those observations that can be directly linked to a violation of regulations—not suggestions, guidance, or other comments. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations.

Items placed on a form 483 are the opinion of the FDA investigator on the scene, and may be subject to review by others within FDA. Current FDA policy requires that the agency write a follow-up letter to clinical investigators and IRBs. When the items on the 483 are confirmed in that letter, they may be taken as an official FDA position. Conversely, there is no guarantee that the follow-up letter will be limited to the items listed on the 483, as additional review by FDA headquarters may identify significant regulatory violations that were not listed on the 483, which will be included in the follow-up letter.

Nevertheless, this does not mean that a 483 should be ignored. A recipient of a 483 should promptly respond to FDA. An effective response addresses each item, indicating agreement and either providing a timeline for correction or requesting clarification of what FDA requires.

Source: Applied Clinical Trials Online

Companies Cozying Up to IFRS

June 26, 2008

After years of resistance to a global accounting overhaul, American companies are rapidly coming around to the idea of adopting international financial reporting standards, a new Deloitte survey of finance executives suggests.

Polling executives at 200 companies, Deloitte found that 30 percent of CFOs and other finance officials would consider adopting IFRS within the next three years if given the option by the Securities and Exchange Commission.

The SEC’s decision to accept IFRS filings from foreign companies, and its signaling that the principles-based standards used in much of the world are likely to take hold here, were factors in the change, the accountancy suggested. Now, U.S. firms are busy considering what this will mean for them.


Powered Industrial Trucks: California’s Requirements for Equipment, Workplace Postings, Safe Operation, and Training

June 26, 2008

According to federal OSHA’s most recent statistics, more than 90,000 workers each year are injured, and 100 workers die, in forklift accidents. Workers are killed when a forklift tips over, when a forklift collides with pedestrians, when the worker is crushed by a forklift, or when the worker falls from a forklift.

This Special Report will help you navigate Cal/OSHA’s sometimes—confusing industrial truck standards, which are arranged differently than federal OSHA’s regulation and have different specific requirements. This Report will also help you ensure that your equipment meets Cal/OSHA standards by providing a comprehensive checklist you can use to inspect your equipment. Safe operating rules—which must be posted in the workplace—and training and instruction requirements are all thoroughly explained.

Download the entire report (PDF)

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