- Delivery Method:
- VIA Electronic Mail
Recipient NameHunter M. Eaves, PharmD
- Surgery Pharmacy Services Inc
3908 Tennessee Avenue, Suite F
Chattanooga, TN 37409-1357
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
October 9, 2020
Case # 610130
From November 18, 2019 to December 6, 2019, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Surgery Pharmacy Services, Inc., located at 3908 Tennessee Avenue, Suite F, Chattanooga, Tennessee 37409. 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 6, 2019. FDA acknowledges receipt of your facility’s response, dated December 26, 2019, as well as your additional correspondence. 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.
Specific violations are described below.
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 did not perform adequate product evaluation and take sufficient remedial actions when microbial contamination was found to be present in the ISO 5 classified aseptic processing area.
2. The investigator observed poor practices during aseptic processing. For example, personnel engaged in aseptic processing, emptied and transferred a trash bag into the ISO 8 area, then resumed aseptic operations in the ISO 5 area without changing gloves and sleeves that came in contact with the trash bin. In addition, personnel engaged in aseptic processing were observed leaning into the ISO 5 classified area with exposed skin (forehead). Further, personnel were observed failing to disinfect supplies at each transition from areas of lower quality to areas of higher quality air.
3. Your ISO 5 classified area had a work surface composed of laminate, which was worn, stained, and chipping.
4. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.
5. Your firm used a non-sterile disinfectant within the ISO 5 aseptic processing area.
6. Your firm 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.
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. 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. You stated that you will revise the media fill assessment to more closely represent your most strenuous production. However, you did not provide documentation for us to fully evaluate your proposed corrections.
2. Regarding the work surface composed of laminate in the ISO 7 area, you stated that you have ceased production within that hood. Further, you stated that you have purchased a new hood. However, it remains unclear whether the laminate hood has been decommissioned and removed from the ISO 7 classified area. The presence of the particle-generating item may adversely impact the air quality in the cleanroom. The difficult to clean surfaces may be a reservoir for microbial contamination.
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 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.
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 of the specific steps that you have taken to correct violations. 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 are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
Please identify your response with FEI 3010704905 and Case # 610130. Send your electronic reply to Dr. Shawn Larson – Compliance Officer at Shawn.Larson@fda.hhs.gov and ORAPHARM2_Responses@fda.hhs.gov.
If you have questions regarding the contents of this letter, please contact Dr. Larson at 214-253-5216.
Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
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.