Inspections, Compliance, Enforcement, and Criminal Investigations

Meditech Laboratories, Inc 10/19/16

  

Department of Health and Human Services logo

 
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502-7070 

 

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Reference No. CMS 506537
 
WARNING LETTER
October 19, 2016
 
Michael B. Bitar, PharmD, Pharmacist-in-Charge
Meditech Laboratories, Inc.
3200 Polaris Ave, #27
Las Vegas, NV 89102
 
 
Dear Dr. Bitar:
 
Between March 10, 2016, and March 18, 2016, U.S. Food and Drug Administration (FDA) investigators conducted an inspection of your facility, Meditech Laboratories, Inc., located at 3200 Polaris Ave., #27, Las Vegas, NV 89102. The FDA inspection was conducted after the Nevada State Board of Pharmacy inspected your facility and reported to the FDA serious concerns regarding sterile compounding practices at your facility. 
 
During the inspection, the FDA investigators observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, our investigators noted that your firm did not have an adequate contact time for your sporicidal agent used to disinfect your aseptic processing areas. Specifically, the 30 minute contact time for (b)(4) appears to be inadequate for sporicidal effect. In addition, our investigators observed stains on the HEPA filters in your laminar airflow hood where sterile drug production occurred. Also, you did not measure pressure differentials during operations and therefore have no assurance that airflow is from areas of higher quality air to areas of lower quality air. Furthermore, your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile products are processed. Therefore, your products may be produced in an environment that poses a significant contamination risk. 
 
A Form FDA 483 was issued to your firm on March 18, 2016. FDA acknowledges your March 5, 2016, action to temporarily cease compounding sterile products and your March 17, 2016, action to voluntarily recall certain sterile products within expiry. 
 
Based on this inspection, it appears that you have produced drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
 
A. Violations of the FDCA
 
Adulterated Drug Products
 
FDA investigators observed that drug products that are 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, our investigators noted that your firm did not have an adequate contact time for your sporicidal agent used to disinfect your aseptic processing areas. Specifically, the 30 minute contact time for (b)(4) appears to be inadequate for sporicidal effect. In addition, our investigators observed stains on the HEPA filters in your laminar airflow hood where sterile drug production occurred. Also, you did not measure pressure differentials during operations and therefore have no assurance that air flow is from areas of higher quality air to areas of lower quality air. Furthermore, your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile products are processed.  
 
Under section 301(k) of the FDCA [21 U.S.C. §331(k)], it is a prohibited act 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 March 5, 2016, action to temporarily cease compounding sterile products and your March 17, 2016, action to voluntarily recall certain sterile products within expiry. We further acknowledge your April 13, 2016, email to the San Francisco District recall coordinator in which you stated that your firm does not intend to resume sterile compounding operations.
 
If you decide to resume production of sterile drugs, FDA strongly recommends that your management immediately undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials (e.g., including procedures for compounding with active pharmaceutical ingredients, taking expiry into account), 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. 
 
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.
 
If you decide to resume sterile operations, 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 if you have taken any specific steps to correct violations, 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 fifteen working days prior to resuming production of any sterile drugs in the future. Your written notification should be addressed to:
 
Lawton W. Lum, Director of Compliance
FDA San Francisco District Office
U.S. Food and Drug Administration
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
 
If you have questions regarding any issues in this letter, please contact Mr. Lance DeSouza via email at Lance.DeSouza@fda.hhs.gov or by phone at (510) 337-6873.
 
  
Sincerely,
/S/ 
Kathleen M. Lewis, J.D.
District Director
San Francisco District
  
 
cc:       
Kim Tran-Ha
23275 S. Pointe Dr., Suite 100
Laguna Hills, CA 92653
 
 
Larry L. Pinson, Executive Secretary
Nevada State Board of Pharmacy
431 W. Plumb Lane
Reno, NV 89509

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