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F0761
E

Expired PPD Antigen Vial Not Discarded per Policy

Greenbrae, California Survey Completed on 09-11-2025

Penalty

No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Summary

A multidose vial of PPD diagnostic antigen was found in the medication refrigerator with an opening date that exceeded the facility's 30-day discard policy. During an observation with the DON, it was verified that the vial had been opened more than 30 days prior and had not been discarded as required. The DON confirmed that the facility's policy is to label multidose vials with the date opened and to discard them after 30 days, in accordance with manufacturer guidelines and facility procedures. Review of the facility's policy and the FDA guidelines for APLISOL also confirmed that vials in use for more than 30 days should be discarded.

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