Inspections, Compliance, Enforcement, and Criminal Investigations

Eastern Pharmacy, Inc. 10/29/14

  

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

Public Health Service
Food and Drug Administration
 
Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
 
Telephone: 407-475-4700
FAX: 407-475-4770

 

VIA UPS NEXT DAY AIR
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-15-02
October 29, 2014
 
Daoud Zayed, Owner
Eastern Pharmacy, Inc.
2046 W Silver Springs Blvd
Ocala, FL 34475
 
Dear Mr. Zayed:
 
From January 30, 2014, to February 4, 2014, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Eastern Pharmacy, located at 2046 W Silver Springs Blvd, Ocala, FL 34475.  FDA inspected your firm after receiving notification from the Florida Department of Business and Professional Regulation describing serious adverse events in at least 37 patients who had received intravitreal injections of Avastin (bevacizumab) or Lucentis (ranibizumab) repackaged by your firm. Based on our observations and on information you provided during the inspection, there are significant deficiencies in your production of sterile drugs including failure to use a functional laminar flow hood and to separate the sterile drug processing area from the common pharmacy area. Furthermore, you repackaged Avastin (bevacizumab) and Lucentis (ranibizumab) by completely removing the rubber stoppers from the sterile, preservative free vials, thus exposing the content to this uncontrolled environment. These practices are of serious concern because they placed sterile drugs at considerable risk of microbial contamination. In addition, as the adverse events associated with your products highlight, the deficiencies in your production of sterile drugs put patients at risk.  
 
A form FDA 483 was issued to your firm on February 4, 2014.
 
A.    Adulteration Charges
 
Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (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 subvisible microorganisms and other contaminants are ubiquitous in an ordinary 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).  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 to be sterile) causes the drug to be prepared, packed, or held under insanitary conditions.
 
FDA investigators observed that your drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have been contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. During FDA’s inspection of your firm, you signed an affidavit describing the practices and methods used in preparing syringes containing Avastin (bevacizumab) or Lucentis (ranibizumab). In this affidavit, you stated that syringes were prepared in a laminar flow hood; however, you also stated that the hood was “not turned on” or “functional” and was only used because it was a flat surface. In addition, you stated that the routine practice for preparing the syringes consisted of opening vials by removing the rubber stopper, then using syringes to produce approximately (b)(4) doses from one vial of Avastin (bevacizumab).  It is important to note that the vials of Avastin (bevacizumab) and Lucentis (ranibizumab) are preservative free. Furthermore, FDA investigators observed that your firm had no door or closure installed to separate the aseptic processing area from the common pharmacy area. 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 adulterated.
 
B.     Corrective Actions
 
We acknowledge receipt of the letter from your attorney, dated February 19, 2014, stating that Eastern Pharmacy has ceased production of sterile products and does not intend to produce sterile products in the future. In addition, we understand that you entered into an agreement on January 13, 2014 with the Florida Department of Health to cease the production of sterile products. 
 
FDA strongly recommends thatif you decide to resume production of sterile drugs, 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 and design. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.
 
C.    Conclusion
 
Please note that the violations cited in this letter are not intended to be an all-inclusive statement of violations that exist 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.
 
If you decide to resume sterile operations, you should take prompt action to correct the insanitary conditions 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 if you have taken any specific steps to address the insanitary conditions at your firm, or you may inform us that you do not intend to resume production of sterile drugs.  If you intend to resume production of sterile drugs in the future, 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. In addition to taking appropriate corrective actions, you should notify this office prior to resuming production of any sterile drugs in the future.  Your written notification should be addressed to:
 
Andrea Norwood, Compliance Officer
FDA Florida District Office
U.S. Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, FL 32751
 
If you have questions regarding any issues in this letter, please contact our office at 407-475-4724. 
 
Sincerely,
/S/ 
Susan M. Turcovski
Director, Florida District

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