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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Dorado Health, Inc.

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

466 Fernandez Juncos Avenue

San Juan, Puerto Rico, 00901

Compliance Branch

Telephone: 787-474-9500

FAX: 787-729-6658

April 2,2009


WARNING LETTER
SJN-2009-06

 

Certified Mail
Return Receipt Requested


Mr. Jorge E. Galva
Executive Director
Dorado Health, Inc.
d/b/a Medical Center Dr. Otero Lopez
Hernandez Carrion Street
Urb. Atenas, Manati, Puerto Rico 00674


Dear Mr. Galva:


During an inspection of your blood bank, located at Hernandez Carrion Street, Urb. Atenas, Manati, Puerto Rico, conducted from November 18, 2008 through December 5,2008, Investigators from the United States Food and Drug Administration (FDA) documented deviations from the Current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of Federal Regulations (CPR), Part 606 (21 CFR 606). These deviations cause your blood products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act (the Act) [21 USC 351(a)(2)(B)]. 


The deviations include the following:


1. Written standard operation procedures were not followed during pretransfusion operation resulting in a failure to take precautions established to identify accurately the recipient blood samples and crossmatched donor units [21 CPR 606.100(b)(8)]. Specifically,


a. Your SOP's titled "Prueba de Compatibilidad" (Compatibility Testing) and "Registro de ABO/Rh de los pacientes con orden de Crossmatch" (ABO/Rh Record of Patients with order for Crossmatch Testing) state that medical technologists must verify if patient had any previous transfusions and compare the ABO/Rh records. In the event there is a discrepancy noted, an investigation must be initiated and resolved prior to utilizing a sample for crossmatch or before a blood product is prepared and released to the patient. On September 3, 2007, one of your laboratory technologists issued two blood units for transfusion to patient (b)(4) without verifying the patient's previous transfusion history as required by the subject SOP. As a result, two type O Positive RBC units (b)(4) and (b)(4) were transfused to patient (b)(4) who was previously transfused with two type A positive RBC units on 8/31/07.


2. Failure to maintain indelible records concurrently with the performance of each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components so that all steps can be clearly traced. [21 CFR 606. 160(a)(1)].


Specifically:


a. Your firm failed to maintain the integrity of the "Blood Donors Record" logbook binder. There were at least ten pages of the logbook that were discarded (page numbers (b)(4) and (b)(4). According to your Blood Bank Coordinator and Medical Technologist they
detached and discarded these pages from the logbook due to clerical errors that needed to be corrected. Each page of this logbook contains (b)(4) entries (or (b)(4) in total) of donor information for example, donor's name, patient's name, donation date, expiration date, ABO and Rh testing, antibody screening, and viral testing that was developed during the year 2007. The pages were not made available for review by our investigator.


3. Failure to initiate and record a thorough investigation, including a record of the conclusions and follow-up for unexplained discrepancies cited in items 1 and 2 above [21 CFR 606.100(c)].


No written response has been received from your firm to the list of inspectional observations (Form FD-483) issued to you on December 5, 2008.


The violations identified above are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment is in compliance with the Act and the cGMP regulations enforced by FDA. You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action without further notice.


Please notify this office in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these violations and to prevent their reoccurrence. If corrective action cannot be completed within fifteen (15) working days, state the reasons for the delay and the time frame within which the corrections will be completed.


Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Rafael Nevarez, Compliance Officer, at 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Nevarez at rnevarez@ora.fda.gov or at (787) 474-9545. You can also find the Act and the blood and blood components regulations through links in FDA's Internet homepage at http://www.fda.gov.


Sincerely,
/S/
Maridalia Torres
San Juan District Director


Enclosure: FDA 483
cc:
Dr. Carlos Disdier
Executive Vice-President
Dorado Health, Inc.
d/b/a Medical Center Dr. Otero Lopez
Hernandez Carrion Street
Urb. Atenas, Manatf, Puerto Rico 00674


Dr. Fidel de Frias
Medical Pathologist and Blood Bank Director
Dorado Health, Inc.
d/b/a Medical Center Dr. Otero Lopez
Hernandez Carrion Street
Urb. Atenas, Manati, Puerto Rico 00674