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Executive Summary

HI-TECH PHARMACAL RESPONDING TO FDA ON TESTING AND LAB SOP INSUFFICIENCIES cited by the agency's Brooklyn, New York District Office in a July 24 warning letter. The letter, signed by District Director Edward Warner, was a follow-up to March 31 and July 2 inspections of the generic OTC manufacturer's Amityville, N.Y. facility. The warning letter cites 11 "serious" violations of the FD&C Act and Current Good Manufacturing Practices regulations. Hi-Tech President Bernard Seltzer said company officials met with FDA district officers on July 28 to respond to the warning letter and were told no action would be taken against the firm pending a reinspection of the facility. Some of the deficiencies uncovered during the FDA inspections have been addressed, while others, including the upgrading of the company's lab operations to conform to FDA standards, are still in progress, Seltzer indicated. Hi-Tech met with agency officials one week before the company completed its initial public offering on Aug. 3 -- 1 mil. shares priced at $6 per share. The offering, proposed in a May 12 preliminary prospectus ("The Pink Sheet" June 1, T&G-7), netted Hi-Tech proceeds of approximately $5.4 mil. Hi-Tech's predecessor company was Ketchum Labs, for which Seltzer was the former VP- sales and marketing. The prospectus outlined a plan by Hi-Tech to focus on Rx-to-OTC switch candidates and to use a substantial portion of the IPO proceeds to build a sterile facility for generic ophthalmic products. The warning letter cites Hi-Tech for failure to follow an adequate stability testing program; test and maintain an adequate batch testing and sample retention program; and establish and follow written procedures for annual quality standards evaluations. Agency inspectors also cited the firm for not having written standard operating procedures (SOPs) for preventing "objectionable microorganisms in drug products not required to be sterile." Additionally, FDA inspectors found that Hi-Tech did not follow lab control mechanisms resulting in "deficient" methods of determining the quality and purity of alcohol in the company's Nite-Time cough medicine, diphenhydramine HCl liquid, Hyco Elixir, Dyphylline GG and Cough Formula 4-D cough/cold products. FDA also cited the company for not having analytical methods for testing the conformance of 26 of its current products to written specifications. Hi-Tech markets approximately 75 cough/cold, decongestant, vitamin and nutritional products. FDA also cited the company for "failure to assure that the written procedures for production and process control are of adequate design to assure that the drug products have the identity, strength, quality and purity they purport" to have. Specifically, the warning letter notes that Hi-Tech did not have any written SOPs for verifying certificates of analysis from raw materials suppliers, for sampling the finished product or for investigating finished products that did not meet specifications. FDA noted that the process validation SOP for assay and pH testing of five samples from different parts of compounding tanks was performed on only one of the company's products, oxymetazoline. Moreover, FDA inspectors found that Hi-Tech personnel were not adequately trained. The agency noted that this situation also applied to lab personnel responsible for microbiology testing of the purified water used in product manufacture.

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