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Executive Summary

CAROLINA MEDICAL CITED FOR MARKETING UNAPPROVED PRODUCTS in an FDA warning letter that also alleges "significant" good manufacturing practices violations uncovered during an Aug. 17-25 inspection of the Farmville, N.C. firm's facility. The Oct. 14 warning letter, from FDA's Atlanta District Office, states that Carolina Medical Products has marketed sodium polystyrene sulfonate (SPS) suspension and triamcinolone acetonide .05% ointment while "no approval of any application effective for such drugs." The warning letter notes that although an ANDA was approved in 1982 for an SPS suspension product, the August inspection discovered a number of unapproved formulation and process changes related to the product. Carolina Medical's records fail to detail any safety assessments of the impact of the process change in the treatment of SPS powder, the warning letter states. An ANDA supplement submitted by the company on June 21, 1993 "does not permit changes to be made until full FDA approval is granted for the supplement submitted covering such changes," the warning letter states. In the warning letter, FDA states that the company's triamcinolone acetonide was "never approved and is clearly marketed illegally." An ANDA for the product filed by the company has been pending at FDA. Carolina Medical issued Class III recalls for triamcinolone acetonide and SPS suspension in late August following the inspection ("The Pink Sheet" Sept. 13, T&G-14 and Sept. 20, T&G- 15). At the time, the company estimated that 300 one-pound jars remained on the market in North Carolina. The firm recalled 200 pint bottles and 75 10-bottle cartons of 60 ml bottles of SPS suspension from Canada. Carolina is continuing to market SPS suspension, but has returned to the method of manufacturing specified in the original 1982 ANDA. FDA cited a number of GMP deviations in the warning letter including: "failure to investigate or provide any justification for disregarding original triamcinolone...stability results; master and batch production records for SPS suspension do not include complete manufacturing instructions and documentation of all critical steps; maintenance of two versions of batch records...; failure to conduct adequate investigations or to formally record an account of the investigation into simethicone drops batch failures; incomplete annual reviews for several products...; and failure to investigate out-of-limit microbial counts in [the firm's] purified water system." The agency requested a description of the corrective steps the company has taken to address the GMP deficiencies. Carolina Medical's response to the FDA warning letter should also include the firm's "marketing plans in regards to SPS suspension product currently in stock and any plans [the company] may have in regards to SPS suspension product previously distributed." The agency noted that it is in receipt of the firm's Sept. 9 response to the August FD-483 inspectional observations and that the "response did not adequately address the issues discussed above." Carolina has submitted its response to the warning letter.

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