- Delivery Method:
- VIA Electronic Mail
Recipient NameJohn C. Rademacher
Recipient TitlePresident and Chief Executive Officer
- HomeChoice Partners, Inc.
3000 Lakeside Drive Suite 300N
Bannockburn, IL 60015
- Issuing Office:
- Division of Pharmaceutical Quality Operations II
April 9, 2020
Case # 606962
From August 13 to August 17, 2018, U.S. Food and Drug Administration (FDA) investigators inspected a subsidiary of Option Care Health, HomeChoice Partners, Inc. dba Bioscrip Infusion Services, at 2848 Washington Road, Augusta, Georgia 30909. The investigators noted serious deficiencies in this facilities practices for producing sterile drug products, which put patients at risk.
FDA issued a Form FDA 483 to your firm on August 17, 2018. FDA acknowledges receipt of your facility’s response, dated August 29, 2018. 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:
1. Your firm failed to sanitize tubing between production of different sterile drug products. The tubing connected to the stock solutions of (b)(4) in IV bags located in the ISO 5 Laminar Flow Hood was not sanitized between the production of different sterile drug products. The investigator observed the operator touching the tubing several times during drug product production. Not sanitizing the tubing between the production of different sterile drug products could contribute to cross contamination of drug products.
2. Prior to cleaning, sterile wipes were introduced into the ISO 5 area for routine daily cleaning and some of the unused wipes were left for cleaning throughout the remainder of the day. The wipes remained open and exposed in the ISO 5 area prior, during, and following cleaning completion. Leaving wipes exposed prior, during, and after cleaning could result in contamination of the wipes. Contaminated wipes used to clean surfaces or other material could result in further contamination of the classified area.
3. Vermin was observed in an area immediately adjacent to your production area. Two live insects were observed inside the ante room beyond the line of demarcation. The technician stepped on one of the insects while wearing full gowning garb and continued to mop the ante room. Shortly thereafter, and prior to completion of mopping, a live spider was observed crawling near the negative pressure room. Vermin is 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.
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 response to the Form FDA 483, dated August 29, 2018.
Regarding the insanitary condition observations in the Form FDA 483, 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. We acknowledge the corrective actions your firm took to triple clean your classified areas, retrain compounding personnel, and perform surface sampling of the clean room space after learning of the insects. Further, you stated that you maintain a contract with a pest control service that treats the building monthly and this contractor will be consulted to perform other measures to prevent insects from entering the building. However, you have not provided supporting documentation of cleaning or the pest remediation actions.
You did not address certain observations related to insanitary conditions, for example:
1. You stated that there is no requirement to sanitize the tubing connected to the stock solutions between different compounded products and the tubing was sterile when it entered the ISO 5 area. Further, you stated that the risk of contamination within the ISO 5 environment is minimal because the compounding technician sanitizes the gloves every 30 minutes. However, you did not provide adequate rational to ensure that the tubing remaining in the ISO 5 hood throughout production of different drug products will not contribute to cross contamination of sterile drug products.
2. You stated that the sterile wipes will not be contaminated since they are held open in the ISO 5 environment. Although the ISO 5 area is intended to be sterile, if the sterile wipes are held open during production, cleaning and when the ISO 5 is not in use, there is a risk for the wipes to become contaminated and the spread of contamination onto other surfaces when used.
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.
Your written notification should refer to the Warning Letter Number above Case # 606962. Please electronically submit your reply, on company letterhead, to: Mark Rivero, Compliance Officer, at ORAPHARM2_Responses@fda.hhs.gov and email@example.com.
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,
David H. Jones, Pharm.D.
HomeChoice Partners, Inc.
dba Bioscrip Infusion Services
2848 Washington Road
Augusta, Georgia 30909-2356
VP of Operations, Southeast
Option Care Health
600 N Broadway #700
Denver, Colorado 80203