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  5. A-S Medication Solutions LLC. - 522197 - 02/25/2019
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CLOSEOUT LETTER

A-S Medication Solutions LLC. MARCS-CMS 522197 — 25/02/2019

A-S Medication Solutions LLC. - 522197 - 02/25/2019


Recipient:
Recipient Name
Walter Hoff
A-S Medication Solutions LLC.
A-S Medication Solutions LLC.

2401 Commerce Drive
Libertyville, IL 60048
United States

Issuing Office:
Center for Drug Evaluation and Research

Silver Spring, MD 20993
United States


Mr. Hoff,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter, dated June 5, 2017. Based on our evaluation, it appears that you have addressed the major violations described in the warning letter for drug products that fall under labeler code 50090. As such, please consider this letter to be a close out of the warning letter.

Although we are issuing this close out, we still expect A-S Medication Solutions (ASM), to continue working on and improving its drug listing files to ensure that complete and accurate drug listing data is submitted to the FDA as required by law. In a final random review of your recent submissions, some minor listing issues were found, which we expect will be addressed by your firm through future corrective efforts. FDA is also aware of several pending submissions which might need further corrections or manual overrides; these potential issues will be evaluated and finalized on a case by case basis.

Please be aware that corrective actions for drug products listed under labeler code 54569 remain unaddressed. As part of the discussions between FDA and ASM, ASM agreed to delist all drug products listed under labeler code 54569, but to date, no SPLs have been submitted to FDA with end marketing dates for those listings. Future FDA regulatory activities will further assess the adequacy and sustainability of the corrections already made and your firm's pending and future submissions.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Paul M. Loebach
Director, Drug Registration and Listing Staff
WO51, Rm2262 10903 New Hampshire Ave
Silver Spring, MD 20993
paul.loebach@fda.hhs.gov