Inspections, Compliance, Enforcement, and Criminal Investigations

Walgreens Infusion Services 8/27/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Food and Drug Administration
 
Dallas District Office
4040 North Central Expressway
Suite 300
Dallas, TX 75204-3128 

 

August 27, 2015
 
2015-DAL-WL-29
 
WARNING LETTER
UPS OVERNIGHT
 
Paul Mastrapa, Chief Executive Officer
Option Care Enterprises, Inc.
RE: Walgreens Infusion Services
485 E Half Day Road, Suite 300
Buffalo Grove, Illinois 60089-8806
 
Dear Mr. Mastrapa:
 
From November 4, 2014, to November 25, 2014, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Walgreens Infusion Services, located at 9030 Kirby Drive, Houston, Texas 77054. This inspection was conducted as a result of a complaint received regarding an adverse event reportedly experienced by a patient who received a magnesium sulfate product that was prepared by this facility. 
 
During the inspection, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators observed that operators poorly maintained the ISO 5 and ISO 7 areas where drug products are compounded. Trash, debris, and dust were observed in aseptic processing areas (e.g., (b)(4) of the laminar air flow hoods). The investigators also observed poor personnel practices (e.g., failure to sanitize glove after wiping sweat from the eyebrow, retrieving a previously sterile glove from the floor and putting it on before beginning aseptic manipulations without sanitizing the glove first or replacing it with a new glove).  Investigators collected a sample consisting of environmental subsamples from multiple locations within the ISO 5 and ISO 7 areas. Testing of the sample found gram-negative, gram-positive, and spore-forming bacteria and mold. Therefore, your products may be produced in an environment that poses a significant contamination risk. 
 
A Form FDA 483 (Inspectional Observations) was issued to your firm on November 25, 2014. FDA acknowledges your December 15, 2014 response to the Form FDA 483. 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
 
Under section 501(a)(2)(A) of the FDCA [21 U.S.C. § 351(a)(2)(A)], a drug is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Numerous microorganisms and other contaminants were present in an aseptic processing environment. 
 
A firm producing sterile drugs must take certain steps in order to ensure removal of contaminants through various controls that focus on safeguarding drug sterility by assuring the quality of the processing environment (e.g., surfaces, personnel, air) and the materials that go into a drug product. Otherwise, drugs that are intended or expected to be sterile may become contaminated during preparation and, when administered to a patient, may result in infections and/or pyrogenic responses that pose a life-threatening health risk to a patient. Failure to take these steps when producing drugs that are intended or expected to be sterile causes the drugs to be prepared, packed, or held under insanitary conditions.
 
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, FDA investigators noted:
 
  1. Debris and dust in areas where aseptic processing is conducted.
 
  1. Poor personnel practices (e.g., failure to sanitize glove after wiping of sweat from the eyebrow while performing aseptic processing and retrieving a previously sterile glove from the floor and putting it on before beginning aseptic manipulations without sanitizing the glove first or replacing it with a new glove.
 
  1. Failure to sanitize supplies and equipment (e.g., carts) entering into aseptic processing areas and failure to use a sporicidal agent in aseptic processing areas, including the ISO 5.
 
  1. Failure to demonstrate through appropriate studies that your hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed.
 
In addition, FDA Laboratory Analysis found gram-negative, gram-positive and spore-forming bacteria and mold in a sample collected from the ISO 5 and ISO 7 areas of your firm’s aseptic processing facility. Therefore, your drug products were produced in an environment that poses a significant contamination risk. 
 
As noted, FDA received a complaint regarding an adverse event reportedly experienced by a patient who received a magnesium sulfate product that was prepared by your firm. FDA collected the remaining magnesium sulfate product from the reporting patient. FDA analysis of this sample found that it contained in excess of 200% of the label claim of magnesium sulfate. Under section 501(b) of the FDCA [21 U.S.C. § 351(b)], a drug is adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. The strength of your magnesium sulfate injection product did not meet the standards set for the drug in the official USP Magnesium Sulfate Injection monograph, which defines magnesium sulfate injection as having no less than 93.0% and no more than 107.0% of the labeled amount of magnesium sulfate, causing it to be adulterated under section 501(b) of the FDCA.
 
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 of the components used to make the drug and results in the drug being adulterated.
 
Misbranded Drug Products
 
Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. As noted, FDA analysis showed that your magnesium sulfate product contained in excess of 200% of the labeled concentration of magnesium sulfate. Because the labeling of this drug product was false, it was misbranded under section 502(a) of the FDCA. 
 
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 of the components used to make the drug and results in the drug being misbranded.
 
B. Corrective Actions
 
We acknowledge your action taken on December 24, 2014, to voluntarily recall all sterile drug products within expiry, and to temporarily cease compounding sterile drug products while your firm addressed the investigators’ observed insanitary conditions. We further acknowledge the documentation and submissions provided by your firm on January 29, 2015, February 9, 2015, and February 12, 2015, addressing the insanitary conditions observed during the inspection and corrective actions taken.   As previously communicated on February, 20, 2015, we have the following comments on the firm’s corrective actions:
 
  1. Corrective actions taken to address FDA’s adverse environmental findings were made without a comprehensive investigation into how the microorganisms entered the ISO 5 and ISO 7 areas. You have not provided any assurance to demonstrate that corrective actions you have taken will be effective in preventing recurrence of this insanitary condition.
 
  1. Your Personnel Validation Procedure via Media Fill Test specified in SOP P-165 Sterile Admixture Quality Control procedure, Revision 12/15/14, does not appear to represent or closely simulate the most challenging or stressful conditions that sterile compounding personnel could experience in your firm, as required by USP <797>, Pharmaceutical Compounding – Sterile Preparation.
 
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 and 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: John Diehl, Compliance Officer, Dallas District Office, 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. John Diehl at 214-253-5288.
 
Sincerely,
/s/ 
Reynaldo R. Rodriguez, Jr.
Dallas District Director
 

cc:

Cliffic A. Guidry, Jr.
Pharmacy Manager & Pharmacist-In-Charge
Walgreens Infusion Services
9030 Kirby Drive
Houston, Texas 77054
 
Charles L. McClure, General Manager
Walgreens Infusion Services
9030 Kirby Drive
Houston, Texas 77054
 
Rachael G. Pontikes, Partner
Duane Morris LLP
190 South LaSalle Street, Suite 3700
Chicago, Illinois 60603
 
Elinor Hart Murarova, Associate
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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