Impax Labs (IPXL) Says Closing of FDA Warning Letter for Hayward Facility May Take Longer than Expected
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Impax Laboratories, Inc. (Nasdaq: IPXL) has provided an update on the status of its resolution of the previously disclosed warning letter issued by the U.S. Food and Drug Administration (FDA) covering its Hayward manufacturing facility.
Late last year, Impax received an acknowledgement letter from the FDA stating that it had received a complete response from Impax to the warning letter. However, a satisfactory re-inspection is required to close out the warning letter and the re-inspection by the FDA has not occurred to date. Therefore, the Company’s previously stated goal for completing the closing out of the warning letter before the end of February 2012 may not occur. Until such re-inspection is completed and the warning letter is closed out, approval of the Company’s pending drug applications listing the Hayward manufacturing facility as a manufacturing location may be withheld by the FDA.
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Late last year, Impax received an acknowledgement letter from the FDA stating that it had received a complete response from Impax to the warning letter. However, a satisfactory re-inspection is required to close out the warning letter and the re-inspection by the FDA has not occurred to date. Therefore, the Company’s previously stated goal for completing the closing out of the warning letter before the end of February 2012 may not occur. Until such re-inspection is completed and the warning letter is closed out, approval of the Company’s pending drug applications listing the Hayward manufacturing facility as a manufacturing location may be withheld by the FDA.
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