WARNING LETTER
ARJ Infusion Services Inc MARCS-CMS 548673 —
- Recipient:
-
Recipient NameMary L. Sackuvich
- ARJ Infusion Services Inc
7930 Marshall Dr.
Lenexa, KS 66214
United States
- Issuing Office:
- Detroit District Office
United States
| |
Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139 |
April 2, 2018
WARNING LETTER
Case # 548673
UPS NEXT DAY
SIGNATURE REQUIRED
Mary L. Sackuvich
President and Owner
ARJ Infusion Services, Inc.
7930 Marshall Dr.
Lenexa, KS 66214
Dear Ms. Sackuvich:
From May 16, 2017, to May 25, 2017, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, ARJ Infusion Services, Inc., located at 7930 Marshall Dr., Lenexa, KS 66214. 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 May 25, 2017. FDA acknowledges receipt of your facility’s response, dated June 14, 2017. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. 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 [21 U.S.C. §351(a)(2)(A)]. For example, during the inspection the investigators observed that:
1. Your main pharmacy technician had not performed a passing media fill at your current facility.
2. 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 may be produced in an environmental that does not provide adequate protection and poses a significant contamination risk.
3. Your firm’s ISO 5 hood has an area of rust with silicone applied over it consisting of approximately ¼” x 1’.
4. Your firm’s ISO 5 hood has what appeared to be a crack along its overhead paneling (b)(4) consisting of approximately 1 linear foot.
5. The pharmacy technician’s beard cover left exposed skin and hair while conducting aseptic practices.
6. Components were not adequately sanitized before placement into the ISO 5 hood.
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.
B. Corrective Actions
We have reviewed your firm’s responses to the Form FDA 483 dated June 14, 2017, and FDA’s request for additional information letter, dated September 1, 2017.
Regarding your responses to observations related to insanitary conditions documented in the Form FDA 483, some of your corrective actions appear to adequately address the deficiencies noted. However, some responses cannot be fully evaluated to determine the adequacy of the corrective actions described because you did not include sufficient information or supporting documentation. Specifically:
In your response to Form FDA 483 Observation #1 you submitted the latest cleanroom certification as well as training documentation that supports your main pharmacy technician media fills training. However, although the certificate from (b)(4), third party contractor, states that dynamic studies were performed with “acceptable” results, the certificate also states some significant recommendations made to your firm regarding your aseptic practices, which would be considered insanitary conditions. There is no evidence these final recommendations were addressed, as updated SOPs related to the aseptic processing or other corrective actions were not provided.
In addition, in your response to Form FDA 483 Observation #3, you stated that your laminar flow hood (LFH) was replaced on (b)(4). However, you continued normal business operations and did not stop production of sterile drug products. Your firm, as stated in your response, “limit compounding to that which was necessary to avoid a disrupt to patient care during the (b)(4) between the time of the inspection and the installation of the new LFH”. You failed to provide the rationale or assessment performed to identify which products needed to be produced and secured sterility of such products. Moreover, no additional corrective actions were implemented.
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.
C. 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 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 working days, state the reason for the delay and the time within which you will complete the correction. If you need additional information or have questions concerning any products distributed through your website, please contact FDA. Please respond within fifteen days of receipt with the actions you plan to take in response to this letter.
Please address your reply via email to: ORAPharm3_Responses@fda.hhs.gov
Eric Mueller, Compliance Officer
U.S. Food and Drug Administration
Division of Pharmaceutical Quality Operations Division III
Your written notification should refer to the Warning Letter Number above (Case# 548673). If you have questions regarding the contents of this letter, please contact Eric Mueller at (402) 331-1101.
Sincerely,
/S/
Art O. CzabaniukProgram Division Director
Division of Pharmaceutical Quality Operations III