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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Arrow International, Inc. 03-Jun-05

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

Public Health Service
Food and Drug Administration


Central Region
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6006

June 3, 2005



Mr. Carl G. Anderson Jr.
President and Chief Executive Officer
Arrow International, Inc.
2400 Bernville Road
Reading, PA 19605


Dear Mr. Anderson:

During an inspection of your firm, Arrow International Inc., located at 2 Berry Drive, Mount Holly, NJ, from March 31 until April 11, 2005, an investigator from the Food and Drug Administration (FDA) determined that you manufacture Percutaneous Thrombolytic (PTD) Catheters. These products are medical devices within the meaning of section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) (21 U.S.C.321(h)).

The above stated inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C.351(h)), in that the methods used in, or the facilities or controls used for manufacturing, packaging, storage, or installation are not in conformance with the Quality System Regulations (QSR) for medical devices as set forth in Title 21, Code of Federal Regulations (CFR) Part 820. The deviations from QSR include, but are not limited to, the following:

1. Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 CFR 820.100 (a)(3). Specifically, nonconforming material report ("NCMR") # 1276 (dated December 1, 2004) documented a manufacturing error of [redacted] the [redacted] used in the 7 Fr PTD catheters [redacted] (failed to meet design specifications). Your firm failed at the time of this nonconformance to initiate a formal corrective action plan, which would include a complete evaluation of the root causes in order to prevent defective PTD catheters from being further distributed.

2. Failure to adequately control the products that do not conform to specifications as required by 21 CFR 820 .90(a). Specifically, NCMR # 1276 was initiated on December 1, 2004 when it was discovered that the [redacted] in lots MC4094934 and MC4105917 did not meet design specifications [redacted]. This investigation into the non- conformance was limited to the [redacted] that your firm had on hand and did not extend to product that was already released for distribution.

3. Failure to control production processes in order to ensure that a device conforms to specifications as required by 21 CFR 820.70(a). Specifically, process document TM-374 was not followed during the production of the [redacted] by allowing production personnel to [redacted] the [redacted] (TM 374 requires the use of a [redacted] in order to achieve correct part length). Your firm allowed production personnel to deviate from the process procedure rather than ensuring that all equipment used in the manufacturing process meets the specified requirements as required by 21 CFR 820.70(g).

Furthermore, production personnel were allowed to use [redacted] to verify the correct length of the [redacted] after {redacted] rather than tool specified in the process document (TM 374 requires [redacted] to measure part length).

4. Failure to have completed procedures for final acceptance activities as required by 21 CFR 820.80(d). Specifically, the inspection instruction used by your Quality Inspectors failed to identify the type of measuring device to use in order to measure the length of the [redacted] (T-65709-024, Lots MC4094934 and MC4105917), which were use in the manufacture of 7 Fr PTD catheters. As a result, your firm failed to use a tool that was suitable for its intended purposes or capable of producing valid results as required by 21 CFR 820.72(a). Defective lots were not detected by your Quality Assurance Unit.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence to each requirement of the Act and FDA's regulations. The specific violations noted in this letter and on the Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems within your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective and preventive actions.

Federal agencies are advised of the issuance of all warning letters about devices so that they may take this information into account when considering the award of contracts.

Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice to you. These actions include, but are not limited to, seizure, injunction and/or civil money penalties.

We have received your written response dated April 21, 2005 to the list of FDA 483 observations. Your response to the first observation does not address when you began to deviate from process document # TM-374 and whether this procedure was followed at your Reading facility. In addition, your response to the third observation does not evaluate your acceptance activity procedures for all devices manufactured at your Mount Holly facility. Furthermore, your response to the fourth observation does not address other devices or components of devices that were [redacted] with your [redacted], which was not working properly (Again, your investigations do not include when these incidents began and what products were affected).

Please notify this office in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.

Your response should be directed to the New Jersey District, FDA, 10 Waterview Blvd., 3rd Floor, Parsippany, New Jersey 07054, Attn: Robert J. Maffei, Compliance Officer.



Douglas I. Ellsworth
District Director
New Jersey District