- Delivery Method:
- VIA Electronic Mail
Recipient NameRaghuveer R. Chintalapally, R.Ph.
- Nanobots Healthcare, LLC dba Assurance Infusion
2626 South Loop West, Suite 555
Houston, TX 77054
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
June 12, 2020
Case #: 608360
From November 13, 2019, to December 3, 2019, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Nanobots Healthcare, LLC dba Assurance Infusion, located at 2626 South Loop West, Suite 555, Houston, Texas 77054. During the inspection, the investigator noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.
FDA issued a Form FDA 483 to your firm on December 3, 2019. FDA acknowledges receipt of your facility’s response, dated January 6, 2020. FDA further acknowledges that your firm ceased sterile compounding on December 19, 2019. FDA also acknowledges that on December 20, 2019, your firm instituted a recall of all drug products intended to be sterile within expiry. 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)].1 Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.
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 [21 U.S.C. § 351(a)(2)(A)]. For example:
1. Your firm produced drug products with materials that had not been verified to assure that they did not contribute endotoxin contamination that may be objectionable given the product’s intended use.
2. Your pharmacy failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
3. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your pharmacy can aseptically produce drug products within your facility.
4. Your personnel engaged in aseptic processing were observed with exposed skin within the ISO 5 hood. Specifically, on November 15, 2019, our investigator observed an operator leaning into the ISO 5 hood and exposing the skin on his forehead. The investigator also observed this same operator placing his gloved hands outside the ISO 5 area to retrieve supplies without sanitizing his gloved hands before re-entry into the ISO 5 hood.
5. Your personnel were observed using non-sterile wipers which were placed on the work surfaces inside the ISO 5 hood for the placement of syringes used during sterile production.
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 response to the Form FDA 483. We acknowledge that your firm ceased sterile compounding on December 19, 2019. We also acknowledge that on December 20, 2019, your firm instituted a recall of all drug products intended to be sterile within expiry.
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 if you decide to resume production of sterile drugs, 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 manufacturing 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 the violations identified above 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 sterile operations, you should take prompt action to correct the violations cited in this letter. Failure to promptly correct these 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 correct the violations cited in this letter, or you may inform us that you do not intend to resume production of sterile drugs. If you intend to resume production of sterile drugs in the future, please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above violated 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) working days prior to resuming production of any sterile drugs in the future.
Your written notification should refer to the Warning Letter Number above (608360). Please address your reply, on company letterhead, to: Mark Rivero, Compliance Officer, at ORAPHARM2_Responses@fda.hhs.gov and firstname.lastname@example.org.
If you have questions regarding the contents of this letter, please contact Mr. Rivero at 504-846-6103.
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Cc: Allison Vordenbaumen Benz, R.Ph., M.S.
Texas State Board of Pharmacy
William P. Hobby Building, Suite 3-500
333 Guadalupe Street
Austin, Texas 78701
1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.