Palm Springs General Hospital, PH 2235. Hialeah, FL
Case No. 2013-04842 – PCP Mesaros/Risch
Count One: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(a), F.A.C. which
requires an anteroom area to be maintained within ISO Class 8 level of particulate contamination.
Count Two: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(f), F.A.C. which
requires the buffer area to be maintained within ISO Class 7 level of particulate contamination and not
contain a sink or drain.
Count Three: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(k), F.A.C. which
requires that the pharmacy compounding parenteral and sterile preparation shall have appropriate
environmental control devices capable of maintaining at least class 100 conditions in the work place
where critical objects are exposed and critical activities are performed.
Terms of Settlement Agreement: Respondent shall be present. Respondent shall pay a fine of
$2,000.00. Respondent shall pay costs of $1,821.10.
Dr. Alphonso was present on behalf of the respondent and was sworn in by the court reporter. The
Respondent was represented by Miles A. McGrane III, Esquire.
Motion: by Dr. Weizer, seconded by Dr. Mikhael, to accept the Settlement Agreement. Motion carried.
Case No. 2013-04842 – PCP Mesaros/Risch
Count One: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(a), F.A.C. which
requires an anteroom area to be maintained within ISO Class 8 level of particulate contamination.
Count Two: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(f), F.A.C. which
requires the buffer area to be maintained within ISO Class 7 level of particulate contamination and not
contain a sink or drain.
Count Three: Section 456.072(1)(k), F.S. (2012) by violating Rule 64B16-27.797(1)(k), F.A.C. which
requires that the pharmacy compounding parenteral and sterile preparation shall have appropriate
environmental control devices capable of maintaining at least class 100 conditions in the work place
where critical objects are exposed and critical activities are performed.
Terms of Settlement Agreement: Respondent shall be present. Respondent shall pay a fine of
$2,000.00. Respondent shall pay costs of $1,821.10.
Dr. Alphonso was present on behalf of the respondent and was sworn in by the court reporter. The
Respondent was represented by Miles A. McGrane III, Esquire.
Motion: by Dr. Weizer, seconded by Dr. Mikhael, to accept the Settlement Agreement. Motion carried.
quoted from Minutes of December 3-4, 2013 Meeting
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