Hill-Rom (HRC) Receives FDA Warning Letter Related to Batesville Plants, Intends to Respond Fully to Requests
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In a Form 8-K, Hill-Rom (NYSE: HRC) disclosed it received an FDA warning letter on March 6th related to an inspection of the company's Batesville, Indiana production plants.
At the close of the inspection, the FDA issued a Form 483 identifying certain observed instances of non-compliance with FDA regulations.
Since the date of the inspection, Hill-Rom has responded to the FDA’s Form 483, and has corrected a number of the observations made by the FDA. However, on March 6, 2012, Hill-Rom received the warning letter, which reiterated the issues raised in the Form 483. The FDA also identified certain instances of non-compliance with FDA requirements regarding the advertising and promotion of certain Hill-Rom products. The warning letter does not restrict Hill-Rom’s ability to manufacture or seek 510(K) clearance of products, nor does it require the withdrawal of any product from the marketplace.
The Company takes these matters seriously and intends to respond fully to the FDA’s requests. Hill-Rom has provided detailed responses to the FDA as to its corrective actions on a regular basis, and will continue to work expeditiously to address all of the issues that the FDA identified. The Company believes that these matters will not have a material impact on the Company’s financial results. However, the Company cannot give any assurances that the FDA will be satisfied with its response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter.
At the close of the inspection, the FDA issued a Form 483 identifying certain observed instances of non-compliance with FDA regulations.
Since the date of the inspection, Hill-Rom has responded to the FDA’s Form 483, and has corrected a number of the observations made by the FDA. However, on March 6, 2012, Hill-Rom received the warning letter, which reiterated the issues raised in the Form 483. The FDA also identified certain instances of non-compliance with FDA requirements regarding the advertising and promotion of certain Hill-Rom products. The warning letter does not restrict Hill-Rom’s ability to manufacture or seek 510(K) clearance of products, nor does it require the withdrawal of any product from the marketplace.
The Company takes these matters seriously and intends to respond fully to the FDA’s requests. Hill-Rom has provided detailed responses to the FDA as to its corrective actions on a regular basis, and will continue to work expeditiously to address all of the issues that the FDA identified. The Company believes that these matters will not have a material impact on the Company’s financial results. However, the Company cannot give any assurances that the FDA will be satisfied with its response to the warning letter or as to the expected date of the resolution of the matters included in the warning letter.
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