- Delivery Method:
- Via Email
Recipient NameMichael R. Repik, D.O.
- Age Management Institute Santa Barbara
533 East Micheltorena Street, Suite 203
Santa Barbara, CA 93103
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
April 18, 2022
Dear Dr. Repik:
From March 22, 2021, to April 12, 2021, a U.S. Food and Drug Administration investigator inspected your facility, Age Management Institute Santa Barbara, located at 533 East Micheltorena Street, Suite 203, Santa Barbara, California 93103. During the inspection, the investigator noted serious deficiencies in your practices for producing products intended or expected to be sterile, which put patients at risk.
The FDA issued a Form FDA 483 to your firm on April 12, 2021. The FDA acknowledges receipt of your facility’s response, dated April 16, 2021. Additionally, the FDA acknowledges that your firm voluntarily ceased production of drug products for IV therapy as of the date of our inspection. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Compounded Drug Products Under the FDCA
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].
B. Violations of the FDCA
Adulterated Drug Products
The FDA investigator noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that:
1. Your facility lacked a certified ISO 5 classified area for sterile compounding.
2. Your aseptic processing areas had difficult to clean and visibly dirty equipment and surfaces. For example:
a. A (b)(4) hood, used to produce drug products purporting to be sterile, had a visibly dirty filter installed. Also, there was staining and peeling paint on the (b)(4) hood surfaces and supporting table.
b. An air vent in the “IV storage and mixing room” was visibly dirty and part of the floor was covered with carpet.
c. A refrigerator with dripping and standing water on the inside shelf was used to store sterile drug products used to produce IV therapy products. The containers/closures were in direct contact with the condensate water.
3. Your firm distributed drug products that were prepared using expired components.
It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.
C. Corrective Actions
We have reviewed your firm’s response to the Form FDA 483. We acknowledge that your firm voluntarily ceased production of drug products for IV therapy as of the date of our inspection.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.
The FDA strongly recommends that if you decide to resume production of sterile drug products, your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.
The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
If you decide to resume operations to produce drugs intended or expected to be sterile, you should take action to correct any violations and ensure such drugs meet the conditions of section 503A, including that the drug products are compounded by a licensed pharmacist in a state-licensed pharmacy or a federal facility or by a licensed physician, before resuming. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to address any violations, or you may inform us that you do not intend to resume production of drugs intended or expected to be sterile. If you intend to resume production of these drugs in the future, please include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate actions to address this matter, you should notify this office fifteen (15) working days prior to resuming production of any drugs intended or expected to be sterile in the future.
Send your electronic reply to ORAPHARM4_Responses@FDA.HHS.GOV or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, California 92612-2506
Please identify your response with unique identifier 625261.
If you have any further questions, please contact Nayan Patel, Compliance Officer, by email at Nayan.Patel1@fda.hhs.gov or by phone at (303) 236-3010.
Steven E. Porter, Jr.
Program Division Director
Division of Pharmaceutical Quality Operations IV