Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Gliatech (GLIA) -- Ignore unavailable to you. Want to Upgrade?

To: Dr. John M. de Castro who wrote (1692)	8/17/2000 7:58:42 PM
From: scaram(o)uche	Read Replies (1) \| Respond to of 2001

FDA determines compliance with the GMP requirements set forth in the Quality System (QS) regulation primarily by factory inspections. An FDA inspection of an establishment, however, can be initiated for a number of reasons. The reasons may be general, such as routine scheduling or a need to obtain data on industries new to FDA or, the reasons may be specific, such as investigation of a consumer or trade complaint, a product defect report, an adverse reaction, or a death. FDA also conducts inspections under the Compliance Status Information Systems (Com STAT) on behalf of the Veterans Administration (VA), Department of Defense (DOD), and Health Resources and Services Administration (HRSA). Upon arrival, the investigator presents his/her credentials and issues a Notice of Inspection form FDA 482. At the end of the inspection, observations are recorded on form FDA 483, List of Observations, and discussed with the manufacturer's management. Later the investigator will write an Establishment Inspection Report (EIR), which is a detailed record of the inspection and findings.