WARNING LETTER

Optum Infusion Services 308 LLC

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/optum-infusion-services-308-llc-647842-12132022

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WARNING LETTER

December 13, 2022

Dear Dr. Kottmer:

From March 8, 2022, to March 18, 2022, a U.S. Food and Drug Administration investigator inspected your facility, Optum Infusion Services 308 LLC, located at
2555 West Fairview Street Suite 104 Building D, Chandler, Arizona 85224. During the inspection, the investigator 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 March 18, 2022. FDA acknowledges receipt of your facility’s response, dated April 8, 2022. 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. You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area. Vermin are a source of microbial contamination. Therefore, your products intended to be sterile were produced in an environment that may not provide adequate protection against the risk of contamination.

2. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

3. An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.

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. Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:

1. In response to Observation 5 of the Form FDA 483, you stated that you changed pest control providers, installed insect light traps, and that you will be installing air curtains on exterior doors and plastic flap curtains inside of the warehouse door. It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.

2. Regarding your response to Observation 1 of the FDA 483, we acknowledge your response indicating that you will update the way you assess and document the risk associated with every “patient compound” potentially affected by an excursion and train staff on the new policy. Also, you stated that you have conducted a retrospective review of “compounds” referenced in the observation and found there to be no product or patient impact. However, your response lacked supporting evidence, for example, you did not provide the retrospective review referenced. Furthermore, we acknowledge your response states, in SOP Compounded Sterile Product Impact Assessment Process, that a low risk level would be determined by the pharmacist in charge (PIC) based on the actionable microbial growth. Please note, any microbial contamination in the ISO 5 area is considered an insanitary condition.

Additionally, your response states, in SOP Compounded Sterile Product Impact Assessment Process, that “(b)(4).” Please note, any microbial contamination within the ISO 5 area is a serious concern and upon recovery, your firm should immediately assess the impact on drug products produced. This assessment should include a thorough evaluation of how contamination could have entered this critical area, and over what period of time the contamination could have existed, as well as drug products that remain on the market that could be affected.

3. In response to Observation 2 of the Form FDA 483, you stated that you provided on-site training to staff. However, you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response.

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.

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 that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of 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. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so.

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 647842.

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.

Sincerely,
/S/
Steven E. Porter, Jr.
Program Division Director
Division of Pharmaceutical Quality Operations IV

CC: Keith McFalls, Regional Vice President (via e-mail k.mcfalls@optum.com)
3428 Wild Oaks Court
Burleson, TX 76028
(817) 676-8760

Filed under: General Problems