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The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1]
In a manufacturing environment, a request for waiver (RFW) is a request for authorization to accept an item which, during manufacture or after inspection, is found to depart from specified requirements, but nevertheless is considered suitable for use as is or after repair by an approved method.
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Inspections are initiated without advance notice, conducted using on-site or telephone and facsimile investigations, performed by trained compliance officers and scheduled based on the following priorities [highest to lowest]: imminent danger; catastrophes – fatalities or hospitalizations; worker complaints and referrals; targeted inspections ...
A request for information (RFI) is a common business process whose purpose is to collect written information about the capabilities of various suppliers. [1] Normally it follows a format that can be used for comparative purposes. An RFI is primarily used to gather information to help make a decision on what steps to take next.
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Pre-shipment inspection (also preshipment inspection or PSI) is a part of supply chain management and an important quality control method for checking the quality of goods clients buy from suppliers. PSI helps ensure that production complies with the governing specification, contract, or purchase order. A final random inspection (FRI) checks ...