Updated: 2005-11-29
REGULATORY ACTION GUIDANCE:
The following represents criteria for deciding when direct reference seizure to *the
Office of General Counsel* through Division of Compliance Management and
Operations (HFC-210) is appropriate:
Any cosmetic product intended for use in the eye area which contains Pseudomonas
aeruginosa.
REMARKS:
Direct reference seizure recommendations should be accompanied by complete
labeling and worksheets. Positive identification using the method found in Chapter
25 of the Bacteriological Analytical Manual (BAM) is necessary to support the
charge. Speciate Pseudomonas isolates using biochemical tests (BAM, Chapter 25)
or appropriate commercial identification kits.
SPECIMEN CHARGE:
The article (was adulterated when introduced into and while in interstate commerce)
(is adulterated while held for sale after shipment in interstate commerce) within the
meaning of the Act, 21 U.S.C. 361(a), in that it contains a poisonous or deleterious
substance, Pseudomonas aeruginosa, which may render it injurious to users under
such conditions of use as are customary or usual.
*Material between asterisks is new or revised.*
Issued: 4/10/91
Revised: 8/96, 5/2005