Michael R. Repik, D.O.
Owner
Age Management Institute Santa Barbara
533 East Micheltorena Street, Suite 203
Santa Barbara , CA 93103
United States
doc@amisantabarbara.comFEI 3018101540Issued Apr 18, 2022Division of Pharmaceutical Quality Operations IV
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3018101540.
Violations0
Issue DateApr 18, 2022
Product TypeDrugs
StatusOpen
Letter Details
Firm
Age Management Institute Santa Barbara
Location
Michael R. Repik, D.O.
Owner
Age Management Institute Santa Barbara
533 East Micheltorena Street, Suite 203
Santa Barbara , CA 93103
United States
doc@amisantabarbara.com
FEI Number
3018101540
Country
United States
Issue Date
April 18, 2022
Issuing Office
Division of Pharmaceutical Quality Operations IV
Product Type
Drugs
Status
Open
Summary
Age Management Institute Santa Barbara, a compounding pharmacy, was cited for producing adulterated sterile drug products for intravenous therapy under insanitary conditions that violated federal manufacturing standards. During a March-April 2021 inspection, the FDA found the facility lacked a certified ISO 5 classified area required for sterile compounding and maintained aseptic processing areas that were difficult to clean and visibly dirty, putting patients at risk of contamination. The company voluntarily ceased production of IV drug products following the inspection and responded to the FDA's Form 483 observations.
Age Management Institute Santa Barbara FDA Warning Letter, April 18, 2022
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