FDA WARNS FIRM FOR INADEQUATE MANUFACTURING PROCEDURES

Biotecx Laboratories lacks adequate procedures for manufacturing and validating its medical devices, according to an FDA warning letter.

Biotecx's Opticoat T3 and T4 enzyme immunoassay kits, which are intended to measure levels of a hormone to diagnose and treat thyroid diseases, are adulterated, the Dec. 8 letter said. An agency investigator found several current good manufacturing practice violations during inspections in September 2006, the letter said. The FDA posted the letter to its website Jan. 23.

According to the agency, Biotecx failed to:

Establish procedures for finished device acceptance;

Verify and validate changes to processes;

Review and approve changes to documents;

Validate device designs;

Document risk analysis procedures;

Ensure equipment calibration met national standards; and

Ensure all equipment was routinely inspected and maintained.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6197d.pdf ( http://www.fda.gov/foi/warning_letters/g6197d.pdf ).

( http://www.fdanews.com/ddl/34_8/ )