I Shay passes inspection with no observations noted

I Shay Cosmetics, Hawthorne, CA, Irvine, CA, District

* Hire a consultant prior to manufacturing OTC drugs;I Shay Cosmetics, Hawthorne, CA, 2/5-9/04, Doc. 109824M, $3 plus retrieval.* Update pest control program to address types of insecticides used and segregation;"I also suggested he review 21 CFR part 210 and 211, as well as visit the FDA website before making any OTC drug products to ensure the firm can manufacture them according to GMPs," the report stated.* Identify, segregate and discard unused, expired and old raw materials;During the close out meeting, Gonzalez also made the following recommendations:Gonzalez reviewed the following procedures, the EIR stated: compounding, sanitizing, packaging, shipping, receiving and laboratory. No objectionable conditions were noted, although Gonzalez did suggest to President Mehdi Ehsan that he approve procedures, as none had approving signatures and dates.Ehsan told Gonzalez that he did not have a complaint-handling procedure "because he has never had a complaint with any products. Ehsan agreed with FDA's suggestion to develop written procedure, written recall procedure and refer to 21 CFR 211 before making any OTC drug products.* Validate equipment; and* Approve all procedures.No 483 observations were noted in an initial inspection of I Shay Cosmetics, Hawthorne, CA, but investigator John Gonzalez from the Irvine, CA, District Office reminded management to review all guidance and GMPs regarding the manufacture of OTC drug products.Regarding manufacturing codes, Ehsan said the firm "assigns a unique manufacturing code and three-year expiration date to finished products." However, the FDAer noted, the company lacked a system to assign the code and no stability studies were on-hand for finished product. "Ehsan promised to develop a system for assigning a unique code to all products and look into the stability issue," the report stated.The EIR noted that I Shay is a custom manufacturer and private labeler of cosmetics and own label distributor of industrial detergents. Products it manufactures include lotions, skin creams, light detergents, dishwashing liquids, car wash products and shampoos, according to FDA records.

I Shay Cosmetics, Hawthorne, CA, 2/5-9/04, Doc. 109824M, $3 plus retrieval.