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  5. Fenwal International, Inc. - 603610 - 06/14/2020
  1. Warning Letters


Fenwal International, Inc. MARCS-CMS 603610 —

Delivery Method:

Recipient Name
Christian Hauer
Recipient Title
President of Transfusion and Cells Technologies Division
Fenwal International, Inc.

Carr 357, Km0.8
Maricao 00606
Puerto Rico

Issuing Office:
Division of Biological Products Operations I

United States

May 14, 2020



Dear Mr. Hauer:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Fenwal International, Inc., located at Carr 357, Km 0.8, Maricao, PR, between September 16, 2019 and September 26, 2019. During the inspection, FDA investigators documented deviations from current good manufacturing practice (CGMP) requirements in the manufacture of your blood-pack units (BPUs) with and without in-line leukoreduction filters, as well as lnterSol, a Platelet Additive Solution (PAS).

At the close of the inspection, FDA issued a Form FDA 483, List of lnspectional Observations, which described a number of significant CGMP deviations from applicable requirements of Section 501 (a)(2)(B) of the Federal Food, Drug and Cosmetic Act (FD&C Act) in the manufacture of your blood-pack unit intermediates. Specific violations include, but are not limited to:


On September 16, 2019, your Microbiology Laboratory did not accurately document test results. Please be advised that incomplete and inaccurate records call into question the integrity of all your microbiological data. The deficiencies include, but are not limited to the following:

1. FDA investigators observed several data discrepancies between recorded microbial plate results and actual observed microbial growth which were verified with the Microbiology Laboratory Manager. Inaccuracies like these create the potential for missing the timely detection of microbiological contamination. For example:

a. Your Microbiology Laboratory Analyst reported (b)(4). The media plate was (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4). FDA investigators found multiple other similar examples of underreporting.

b. Your Microbiology Laboratory Analyst failed to document the CFU Total Count value for (b)(4). The media plate was subsequently (b)(4). However, your Microbiology Laboratory Manager counted (b)(4) CFUs on the (b)(4).

2. Per SOP MA-03-01-013, entitled "Buenas Practicas De Documentacion", changes to original (b)(4). However, bioburden data results for batch FM19I10017 were (b)(4) by your Microbiology Laboratory Analyst (b)(4).

3. (b)(4).


We have reviewed your written responses, dated October 18, 2019, December 20, 2019, February 20, 2020, and April 24, 2020 to the Form FDA 483. We acknowledge the corrective actions you represent that you have taken in response to the observations, your commitment to implement additional corrective actions, and your plan to provide updates. However, we have concerns regarding the adequacy of your corrective actions to date including, but not limited to the following:

Form FDA 483 Observation 1
Your written response acknowledges the significance of your microbial growth count discrepancies; however, at this time it is unknown how long these practices of underreporting, or failure to report, took place, and how widespread these practices were.

The data integrity breaches identified during our inspection raise serious concerns regarding the validity of all results documented by your quality control laboratory. We acknowledge your decision to retain third-party oversight of Microbiology Laboratory tests and data documentation and several other remediation measures until full confidence is restored in the Microbiology Laboratory.
However, your response is inadequate in that it lacks:

• Your market action plan if any batches fail to meet the criteria for the statistical verification testing for sterility.

• An update regarding investigation 593423 (b)(4) of your October 2019 response) pertaining to (b)(4) End of Batch that exceeded the Total Count alert limit, as this was not provided for review.

Form FDA 483 Observation 5
Your response lists over 350 complaints with various extensions, dating as far back as July 30, 2018, some remaining open to date. Descriptions of these investigations include "leak before use," "particulate matter," "discolored solution," and "mold." Please provide a timeframe for completing these investigations.

Data Integrity Remediation
Your quality unit does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. Please see FDA's guidance document Data Integrity and Compliance with Drug CGMP for recommendations on establishing and following CGMP compliant data integrity practices at:


The deviations identified above are not intended to be an all-inclusive list of violations at your facility. The deviations are an indication that your quality control unit is not fulfilling its responsibility to assure the identity, strength, quality, and purity of your drug product(s). It is your responsibility to ensure that your establishment fully complies with the law. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations in all your facilities. You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice.

We request that you respond in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include any documentation necessary to show that the corrective actions have been achieved. If you cannot complete all corrections within fifteen (15) working days, please explain the reason for your delay and the time frame within which the remaining corrections will be completed.

Your response should be sent to the following address: U.S. Food and Drug Administration, Helen Ricalde, 222 Bloomingdale Rd., Rm. 406, White Plains, NY 10605, or emailed to helen.ricalde@fda.hhs.gov. If you should have any questions, please contact Helen Ricalde, Compliance Officer, at (914) 682-2826 Ext. 26, or via email.

Elizabeth A. Waltrip
Program Division Director
Office of Biological Products Operations - Division I

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