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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Las Americas Laboratory & Blood Bank, Inc. 21-Feb-02

DEPARTMENT of Health and Human Services

Food and Drug Administration

466 Fernandez Juncos Avenue

Puerte De Tierra

San Juan, Puerto Rico 00901-3223

 

WARNING LETTER

SJN-02-07

February 21, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Dr. Rafael Rizek

Blood Bank and Transfusion Services Director

Las Americas Laboratory and Blood Bank, Inc.

400 Domenech Avenue, Suite 203

Hato Rey, PR 00918

Dear Dr. Rizek:

From December 4 to December 12, 2001 an investigator from our office conducted an inspection of your licensed hospital blood bank, located at the above listed address. The investigator documented deviations from the requirements of Biological Products: General, Title 2 1, Code of Federal Regulations, Part 600 (21 CFR 600) Current Good Manufacturing Practices (GMP? s) for Blood and Components, 21 CFR 606 and Additional Standards for human Blood and Blood Products, 21 CFR 640. These deviations cause the Blood and Blood products manufactured and tested by your firm to be adulterated within the meaning of section 501 (a) (2) (b) of the Food, Drug and Cosmetic Act (the Act).

The deviations reported were as follows:

1. Failure to store and handle platelets as described in 2 1 CFR 640.24(d) and 21

CFR 640.25(a), which require that, immediately after separation, the platelets

be stored at either 20 to 24?C with gentle agitation or 1 to 6 degrees C with optional

agitation.

The inspection found that platelets are routinely stored in a shaker at room

temperature with no air conditioning or temperature monitoring.

2. Failure to promptly notify the Center for Biologics Evaluation and Research

(CBER) of errors as required by 21 CFR 600.14.

The inspection found that an error, which resulted in the issuance of a unit of

incorrect group and type for transfusion in June 2000, was never reported to

CBER.

3. Failure to have a system to record, document and investigate discrepancies

related to the quality of blood products as required by 21 CFR 606.100 (c).

4. Failure to follow appropriate donor screening procedures as required by 21

CFR 640.3. For example during the inspection the following was observed:

a. The donors were interviewed in the reception area, which did uot provide

adequate privacy, and the interviews were interrupted for the conduct of

other business by the interviewer.

b. The interviewer did not physically examine the donors? arms for indication of intraveuous drug use.

c. The interviewer did not check the donor deferral files to determine if prospective donors were previously deferred due to positive viral marker test results.

d. Self-exclusion cards, which are required by your procedures to be completed before donations are released for transfusion, were not provided to donors during the inspection. In addition, review of the records found several additional units, which were released without the self-exclusion card being included in the records.

5. Failure to maintain adequate records of the processing and distribution of blood as required by 21 CFR 606.160(b) & (c). For example:

  1. At least 45 records for the period from l/1/00 to 12/12/01 did not include a record of the individual who physically received the unit from the blood bank.
  2. The blood types of at least two units were illegible in the cross-match records.

c. There was no Du test record in the log for at least out unit, which was

reported as Rh negative.

The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure that your establishment with all requirements of the federal regulations.

You should take prompt measures to correct these deviations. Failure to promptly

correct these deviations may result in regulatory action without further notice.

Such action includes seizure and/or injunction.

Please notify this office in writing, within 15 working days of receipt of this letter,

of the specific steps you have taken to correct the noted violations and to prevent

their recurrence. If corrective action cannot be completed within 15 working

days, state the reason for the delay and the time within which the corrections will

be completed.

Your reply should be sent to the address on the letterhead above to the attention of

Mary L. Mason, Compliance Officer.

Sincerely,

Wayne Matthews for

District Director