CETYLITE INDUSTRIES'CETYLCIDE-G AND CETYLCIDE REQUIRE 510(k)s,

Executive Summary

CETYLITE INDUSTRIES'CETYLCIDE-G AND CETYLCIDE REQUIRE 510(k)s, FDA notifies the manufacturer of medical device sterilants and disinfectants in a Feb. 3 warning letter. The agency says that at least three lots of Cetylcide-G, a sterilant/disinfectant for surgical instruments, have been shipped since June 1991 without premarket clearance. The warning letter is a result of an inspection of the firm's Pennsauken, New Jersey facility which took place between Dec. 22 and Jan. 8. FDA says in the letter that Cetylite not only failed to receive marketing clearance for Cetylcide-G and Cetylcide (a diluent for Cetylcide-G), but that the firm also violated several good manufacturing practices regulations in the production of Cetylcide-G, Cetylcide, and two other products, Zarosen and Varnal. For example, FDA says device master records have not been established for the manufacture of Cetylcide-G and Cetylcide. FDA notes a lack of written procedures for: * * "detailing the use and maintenance of the water deionizing and filtration system," * * "cleaning the multiple-use mixing tank," * * "describing the manner and specified quantity of water added to the bulk mix tank," * * and "the mixing order of batch ingredients." The agency says that written procedures have also not been established regarding finished device inspections that must take place prior to distribution. Additionally, FDA says the firm's master production and control record for specific lots of Zarosen and Varnal were not prepared, dated and signed by a designated individual. The Cetylite warning letter was one of several released by FDA during the weeks of Feb. 15 and 21. Other warning letters included one sent to Dallas-based Hydro-Med Products (see box, I&W-8, for a listing of all medical device related warning letters released during the period). The Hydro-Med letter was a result of an inspection of the Dallas facility which took place Jan. 7 through 20. The firm was cited by FDA for GMP deficiencies related to the manufacture of its sterile surgical drapes and spinal needles. The deficiencies included: the failure * * "to have complete documentation to support validation of such manufacturing operations as [ethylene oxide] sterilization and finished device package sealing," * * to "follow established written procedures in areas of quarantine/release of finished devices and control of ETO chamber processing temperatures," * * and "to establish environmental controls and procedures for the clean room used to produce spinal needles."