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483
•Interlectric Corporation•December 6, 2011

Interlectric Corporation – FDA 483, Dec 6, 2011

Record Details

An FDA inspection of Interlectric Corporation, a device manufacturer, revealed that the firm has been manufacturing and marketing a red lamp product (model RV620) for red light therapy since 2008. The company failed to obtain marketing approval or clearance from the FDA for this product prior to its sale and has not requested it to date. This indicates a significant regulatory non-compliance regarding device marketing.

Company
Interlectric Corporation
Inspection date
December 6, 2011
Product type
device
Office
Philadelphia District Office
Person
  • James M. O"Donnell (investigator)
View Company Profile

ID · a9d70037-3004-4a84-a664-e6d8bb6eb759

Other documents for Interlectric Corporation
  • WARNING_LETTER - 2011-12-06December 6, 2011

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