The QMN Weekly Bulletin

'Unclean' Conditions Cited in FDA Warning Letter

Feb. 1, 2008

Unsanitary manufacturing conditions at Amico Laboratories were cited in a recent FDA warning letter.

The company, which makes in vitro diagnostic test kits, failed to prevent equipment and product contamination by substances that could affect product quality, according to the letter.

Distilled water used in manufacturing is obtained from a hand-washing sink in the plant’s restroom, the Jan. 3 letter said. The sink was in poor repair and was “unclean,” with the toilet approximately four to five feet from the distillation unit and sink, the letter added.

Amico Laboratories President Abdallah Isa said it “doesn’t make much sense” that the company received the letter. He asked the FDA inspector if the firm would be sent a letter and was told it would not. He added that Amico would respond to the FDA.

The warning letter, which was posted recently to the FDA’s website, can be found at www.fda.gov/foi/warning_letters/s6634c.pdf.