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May 18, 2022

WARNING LETTER
Case # 633440

Dear Mr. Ennenbach:

From August 23, 2021, to August 27, 2021, U.S. Food and Drug Administration (FDA) investigators inspected your facility, New Vitalis, LLC dba New Vitalis Pharmacy, located at 4139 Cadillac Court, Suite 201, Louisville, KY 40213. During the inspection, the investigators noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your firm on August 27, 2021. FDA acknowledges receipt of your facility’s responses, dated September 9, 2021, and September 17, 2021. FDA also acknowledges that on September 22, 2021, your firm initiated a voluntary recall of all Testosterone Cypionate/Testosterone Propionate 180mg/mL, 20mg/mL within expiry produced on or prior to September 7, 2021 due to lack of sterility assurance. FDA further acknowledges that your firm voluntarily ceased all sterile compounding effective September 7, 2021. 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 investigators 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 investigators observed:

1. Vermin were observed in an area immediately adjacent to the firm’s production area.
2. Production areas were difficult to clean or contain porous, particle generating, or visibly dirty surfaces. Specifically, debris on the floor, peeling (b)(4) tape with an apparent build-up of black residue on the floor in the ISO 7 cleanroom, and black residue build-up around (b)(4) HEPA filters were observed.
3. An operator blocked first air by placing gloved hands directly over open sterile containers.
4. HEPA filters were not sealed around each perimeter to the support frame.
5. Personnel failed to disinfect gloves and components to prevent contamination.
6. Personnel donned gowning apparel improperly in a way that may have caused the gowning apparel to become contaminated.
7. Your firm handled hazardous drug products without providing adequate cleaning of utensils to prevent cross-contamination.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, 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 responses to the Form FDA 483. FDA acknowledges that on September 22, 2021, your firm voluntarily recalled all Testosterone Cypionate/Testosterone Propionate 180mg/mL, 20mg/ML within expiry produced on or prior to September 7, 2021 and ceased all sterile compounding effective September 7, 2021.

Regarding your responses related to the insanitary conditions, we cannot fully evaluate the adequacy of your corrective actions because no official response has been submitted and therefore did not address the observations related to insanitary conditions.

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.

FDA strongly recommends that your management 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.

D. Conclusion

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 prompt action to address any violations. 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 of the specific steps you have taken 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 drugs intended or expected to be sterile 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. This letter notifies you of our concerns and provides you an opportunity to address them. 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 corrective actions, you should notify this office fifteen (15) days prior to resuming production of any drugs intended or expected to be sterile in the future.

Your written notification should refer to the Warning Letter above (WL # 633440). Please address your reply via email to: [email protected]

Attention: Russell K. Riley, Compliance Officer
U.S. Food and Drug Administration
Division of Pharmaceutical Quality Operations III

If you have questions regarding the contents of this letter, please contact Russell K. Riley at (630) 277-1908.

Sincerely,
/S/

Jeffrey D. Meng
Program Division Director
Pharmaceutical Quality Operations Division III

cc:

Michael Kellihan, Pharm.D., Pharmacist-in-Charge
New Vitalis, LLC
dba New Vitalis Pharmacy
4139 Cadillac Court, Suite 201
Louisville, KY 40213-1578