John C. Rademacher
- Walgreens Infusion Services
3000 Lakeside Drive, Suite 300N
Bannockburn, IL 60015
- Issuing Office:
- Dallas District Office
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U.S. Food & Drug Administration
Dallas District Office
4040 N. Central Expressway, Suite 300
Dallas, Texas 75204
October 19, 2016
Paul Mastrapa, Chief Executive Officer
Option Care Enterprises, Inc.
RE: Walgreens Infusion Services (San Antonio, TX)
1411 Lake Cook Road, MS L321
Deerfield, IL 60015
Dear Mr. Mastrapa:
Between July 20, 2015, and August 6, 2015, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Walgreens Home Care, Inc. dba Walgreens Infusion Services, located at 14220 Northbrook Drive, Suite 100B, San Antonio, TX 78232-5045. We note that as a result of a change in ownership the facility now operates under the Option Care name.
During the inspection, the investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigators observed poor personnel aseptic practices. Specifically, while performing aseptic operations, a technician leaned forward into the ISO 5 hood resting both elbows on the hood and covering the ventilation grid. A deposit of liquid filth was observed on the floor of the cleanroom directly under the ISO 5 hood during aseptic processing. In addition, the Investigator observed what appeared to be hundreds of dead insects throughout the warehouse area where various drug products are stored. Our investigators noted that your firm performs environmental monitoring after routine cleaning procedures.
A Form FDA 483 was issued to your firm on August 6, 2015. FDA acknowledges your August 27, 2015, response to the Form FDA 483 and your December 22, 2015 response regarding the insanitary conditions.
Based on this inspection, it appears that you are producing drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Violations of the FDCA
Adulterated Drug Products
The FDA investigators observed that your 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, the investigators observed poor personnel aseptic practices. Specifically, while performing aseptic operations, a technician leaned forward into the ISO 5 hood resting both elbows on the hood and covering the ventilation grid. A deposit of liquid filth was observed on the floor of the cleanroom directly under the ISO 5 hood during aseptic processing. In addition, an estimated hundreds of dead insects were observed throughout the warehouse area where various drug products are stored. Our investigators noted that your firm performs environmental monitoring after routine cleaning procedures.
Furthermore, FDA Laboratory Analysis found gram-negative, gram-positive and spore-forming bacteria in a sample collected from the ISO 5 and ISO 7 locations within your firm’s aseptic processing area.
It is a prohibited act under section 301(k) of the FDCA 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 acknowledge your actions taken in November 2015, to voluntarily recall sterile drug products within expiry, and to (b)(4). We further acknowledge your December 22, 2015, response addressing the insanitary conditions observed during the inspection and corrective actions taken. As previously communicated to you in our February, 19, 2016, letter, you have not provided a sufficient root-cause evaluation into the microbial contamination identified by FDA environmental monitoring. In addition, the draft Pest Control proposal included in your response does not address the prevention, destruction, repellence, or mitigation of the specific pests that were found in the warehouse that stored drug products.
FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant aseptic processing expertise could be useful 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 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 the corrective actions within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please address your reply to: Attn: Acting Dallas District Director, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204.
If you have questions regarding the contents of this letter, please contact Mr. Jeff Wooley, Compliance Officer, at 214-253-5251.
Acting Dallas District Director
Joshua D. Vinson
Walgreens Home Care, Inc. dba Walgreens Infusion Services
14220 Northbrook Drive, Suite 100B
San Antonio, TX 78232-5045
Rachael G. Pontikes, Partner
Duane Morris LLP
190 South LaSalle Street, Suite 3700
Chicago, Illinois 60603
Gay Dodson, RPh, Executive Director
Texas State Board of Pharmacy
William P. Hobby Building
Tower 3, Suite 600
333 Guadalupe Street
Austin, Texas 78701
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