Warning Letter - IPQ

We acknowledge your firm's response of June 15, 2012 and your continued commitment to recall all
human and veterinary drug products compounded since November 21, 2012 and to suspend sterile
compounding operations at least until observations documented on the Form FDA 483 issued to your firm
on May 11, 2012, have been adequately resolved. If at a later date your firm decides to resume sterile
compounding operations, FDA strongly recommends that you retain an independent expert, who is
knowledgeable and experienced in sterile compounding, to assist you in implementing appropriate sterile
compounding procedures and conditions, as required by law. In addition, we acknowledge your
commitment to notify FDA well in advance of any resumption of sterile compounding operations and
request that you submit all relevant SOPs to the Agency at that time for our review.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific
steps that you have taken to correct violations. Include an explanation of each step being taken to prevent
the recurrence of violations and copies of supporting documentation. If you cannot complete corrective
action within fifteen working days, state the reason for the delay and the date by which you will have
completed the correction. Your reply should be sent to the attention of: Winston Alejo, Compliance
Officer, Food and Drug Administration 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you
have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Sincerely,
/S/
Emma R. Singleton
Director, Florida District