FDA publishes timeframe for company response to facility inspections.

The Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration. ) has announced a program establishing a timeframe for the submission Submission
Elliott, Anne

reluctantly gives up her fiancé on her family’s advice. [Br. Lit.: Jane Austen Persuasion in Magill I, 734] and agency review of post-inspection responses.

Details regarding the plan were published in the Federal Register on August 11. The program is scheduled to begin September September: see month. 15.

The plan specifies that following an FDA inspection of a facility, the agency will issue a form FDA 483, Inspectional Observations, notifying no·ti·fy
tr.v. no·ti·fied, no·ti·fy·ing, no·ti·fies
1. To give notice to; inform: notified the citizens of the curfew by posting signs.

2. management of any objectionable conditions or violations of federal code discovered during the inspection.

Company objections, correctional cor·rec·tion
n.
1. The act or process of correcting.

2. Something offered or substituted for a mistake or fault: made corrections in the report.

3.
a. actions taken or planned correctional actions responding to inspection observations noted on the form may be discussed with the FDA inspector or submitted to the FDA at the address on the form. Companies have 15 business days to respond to inspection observations.

If the agency has not received communication from the company within 15 business days following the issuance of form FDA 483, the agency will proceed to issue a warning letter to the company for violations cited.

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Title Annotation:	AFFI's Washington Watch
Publication:	Frozen Food Digest
Date:	Oct 1, 2009
Words:	160
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