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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hunterdon Medical Center 03-May-04

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

Public Health Service
Food and Drug Administration

 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6009


May 3, 2004

WARNING LETTER

CERTIFIED MAIL-
RETURN RECEIPT REQUESTED

Robert Wise
President/CEO
Hunterdon Medical Center
2100 Wescott Drive
Flemington, New Jersey 08822

Dear Mr. Wise:

File No: # 04-NWJ-11

During an inspection of your unlicensed blood bank located at 2100 Wescott Drive, Flemington, New Jersey on January 29 to February 12, 2004, our investigator documented significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components, Title 21, Code of Federal Regulations (CFR) Parts 606 and 640. 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). These deviations were documented on the Form FDA 483 issued at the conclusion of our inspection and include, but are limited to the following:

1. Failure to maintain accurate records which identify unsuitable donors so that products from such individuals will not be distributed, as required by 21 CFR 606.160(e). For example, in June 2003, it was discovered that all donor cards from the year 2000 were inadvertently destroyed. Without the original donor record, there is no assurance that all deferred donors from that year were appropriately entered into your computerized donor system.

In addition, your staff failed to comply with your own procedure, SOP QP 4-3-2000, Laboratory Incident Form, which requires a documented supervisory review and recommendation to prevent reoccurrence of similar incidents, which is also required by 21 CFR 606.100(c).

2. Failure to maintain records that establish scientifically sound and appropriate specifications, standards and test procedures, as required by 21 CFR 606.140(a). For example, test records to support the installation and validation performed on the [redacted], which was conducted by an [redacted] representative, were not maintained at your blood bank.

Also, there are no written procedures or formal instructions describing the operation, maintenance and calibration for the [redacted] unit, as required by 21 CFR 606.100(b). Your staff refers to the manufacturer’s manual for operations and maintenance.

3. Failure to maintain equipment used in the processing of blood and blood products, to facilitate cleaning and maintenance, as required by 21 CFR 606.60(a). For example, there is no documentation to support the cleaning of the [redacted] track in the [redacted] unit for 6 out of 7 months during 2003. A monthly cleaning schedule is recommended in the manufacturer’s manual, which as previously noted, your staff follows in lieu of written procedures.

Also, there was no documentation to support that start-up and shutdown procedures were performed on the [redacted] unit for testing runs conducted on April 9, 11, 17 and 24, 2003.

4. Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred, as required 21 CFR Part 606.171. For example, on 1/03/03 your staff discovered that unit [redacted] was labeled with an incorrect expiration date of 1/30/03. The error was discovered on 1/03/03, the same date the unit was transfused. An investigation determined the numbers were transposed when entered into your computer system.

Additionally, your investigation of this dating error failed to comply with your own procedure, SOP QP 4-3-2000, Laboratory Incident Form, which requires a documented supervisory review and recommendation to prevent reoccurrence of similar incidents, which is also required by 21 CFR 606.100(c).

5. Failure to establish adequate procedures for preparing the phlebotomy site in a manner to give maximum assurance of a sterile environment as required by 21 CFR 640.4 (f). For example, your written procedure, SOP DR 3-3-97 Donor Arm Preparation, describes the use of 1% povidone-iodine swabstick for arm preparation, when in fact the swabstick is labeled to contain 10% povidone-iodine. Also, as allowed by your procedures, our investigator observed your staff removing the prep solution with an acetone/alcohol swabstick. The removal of the prep solution is an alternate procedure for patients sensitive to iodine, which is not clearly described in your procedure.

The above deviations 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 all applicable regulations.

You should take prompt measures to correct these deviations. Failure to promptly implement corrective actions may result in regulatory action without further notice. Such action may include seizure and/or injunction.

We acknowledge receipt of your firm’s response, dated March 16, 2004, to the Form FDA 483. Although it appears from your response that you are working toward correcting the deviations noted at your firm, you must adequately implement and maintain each corrective action to ensure its effectiveness. We will verify the adequacy of your corrective actions during our next inspection. Moreover, several items remain incompletely addressed or raise additional questions. For example, it is not readily apparent from your response to Observation 1 that you recognize the importance of considering additional actions you must take after correcting the deviations to prevent their recurrence. Moreover, your response to Observation 3 is incomplete in that you do not address the need for your firm to maintain the documentation to support the satisfactory installation and validation of the [redacted] unit. In addition, your responses to Observations 5 and 6 are inadequate in that the procedure submitted with your response lacks a section for supervisory review to assure that the [redacted] unit is cleaned and properly maintained. Further, although your response to Observation 7 appears to be adequate, you must validate any alternate method, as you have noted, prior to implementation. Finally, with regard to Observation 2, the donor cards that were destroyed were from 2000, not 2003 as you have referenced in your response.

We request you notify this office in writing, within fifteen (15) working days of receipt of this letter, of the additional steps you have taken to correct the noted deviations and to prevent their recurrence.

Your response should address the comments listed above and include examples of documentation demonstrating that corrections have been implemented. If corrective action can not be completed within 15 working days, state the reason for the delay and the timeframe within which corrections will be completed.

You should address your written response to the Food and Drug Administration, New Jersey District Office, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Mercedes B. Mota, Compliance Officer.

Sincerely,

/s/

Douglas I. Ellsworth
District Director
New Jersey District