Company: Custom Ultrasonics, Inc.
Subject: Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals
Issuer: Seattle District Office
Issued: June 21, 2005 Closed:
Not applicable.
Source ucm075455 Archive Code:

Custom Ultrasonics, Inc. 21-Jun-05

Department of Health and Human Services

Public Health Service
Food and Drug Administration

900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390


June 22, 2005



Mr. Frank J. Weber, President & CEO
Custom Ultrasonics, Inc.
144 Railroad Drive
Ivyland, PA 18974-1449

Dear Mr. Weber:

During an inspection of your establishment located in Ivyland, Pennsylvania, on January 18 ; 2005, through February 15, 2005, our .Investigator determined that your firm manufactures a washer/disinfector for endoscopes. The System 83 Washer/Disinfector is a medical device under 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,the System 83 Washer/Disinfector is adulterated under 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, its manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices set forth in the Quality System (QS) regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:

1) Failure of management with executive responsibility to ensure that an adequate and effective quality system is implemented and maintained at all levels of the organization as required by 21 CFR 820.20. For example, the firm has not established a quality policy or plan and has not conducted quality audits or management review. The firm has no management representative responsible for ensuring that quality system requirements are effectively established and maintained.

2) Failure to establish complaint handling procedures for receiving, reviewing, and evaluating complaints as required by 21 CFR 820.198. For example complaints involving the possible failure of a device to meet its specifications were not reviewed, evaluated, and investigated. Examples of such complaints are:

MedWatch Report, dated 12/21/98
MedWatch Report, dated 1/9/04
Multiple MedWatch Reports, dated 09/2'9/04
MAUDE Database/Report #511790
MAUDE Database/Report #512172

3) Failure to establish, define, document, and implement procedures to control the design process of the device as required by 21 CFR 820.30(a). For example, the design and development of the Min-Flex Ear, Nose, and Throat.(ENT) endoscope Washer/Disinfector was not developed in accordance with design controls. There are no records of established design inputs, outputs, reviews, verification/validation testing, risk analysis, and a design history file.

4) Failure to establish, define, and document procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation as required by 21 CFR 820.30(i). For example, the following design changes on the System 83 Plus Endoscope Washer/Disinfector were not made in accordance with a design change control procedure:

1. 1998 [redacted]

2. 2002 [redacted]

3. 2002 [redacted]

4. 2004 [redacted]

5) Failure to implement procedures for acceptance or rejection of finished device production runs, lots, or batches as required by 21 CFR 820.80(d). For example, the following System 83 Plus Washer/Disinfectors were distributed into domestic commerce, without Quality Control approval: Serial Nos. [redacted] and [redacted] .

6) Failure to establish, define, and document procedures for acceptance or rejection of incoming product as required by 21 CFR 820.80(b). Specifically, there were no written instructions for the acceptance testing of the following components used in the manufacturing of the System 83 Plus Washer/Disinfector: [redacted] Additionally, the ultrasonic transducer and ultrasonic generator components are not tested in accordance with established procedures.

7) Failure to define and document procedures for addressing the identification, documentation, evaluation, segregation, disposition, and investigation of nonconforming product as required by 21 CFR 820.90(a). Specifically, no written procedures have been established for nonconforming product. For example, no documentation was presented concerning investigation and disposition or the reason for the segregation of 12 rejected in process ultrasonic processing chambers observed on a shelf in the manufacturing room.

8) Failure to clearly identify throughout manufacturing the acceptance status of product as required by 21 CFR 820.86. For example, 12 rejected in process ultrasonic processing chambers observed on a shelf in the manufacturing room were not identified with an acceptance status.

Additionally, the above stated inspection revealed that your devices are misbranded under Section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. 3601, respecting the device and 21 CFR part 803 - Medical Device Reporting (MDR) regulation. Specifically, you failed to submit MDR reports to FDA after receiving information which reasonably suggested that one of your commercially distributed devices may have caused or contributed to a serious injury. The results of a review and investigation of MedWatch reports that were reported to your firm regarding complaints of patients that tested positive for Hepatitis C antibody post exposure to an endoscope that was not disinfected properly by the System 83 Plus Washer/Disinfector should have been reported as a serious injury as required by 21 CFR 803.50 (a) (1).

Additionally, the above-stated inspection revealed that written Medical Device Reporting procedures have not been developed as required by 21 CFR 803.17. Medical Device manufacturers are required to develop, maintain and implement written MDR procedures. Specifically, there is no documentation that the following complaint information received by the firm concerning the System 83 Plus Washer/Disinfector was reviewed, evaluated and investigated as a complaint and to determine,whether the events were MDR reportable:

MedWatch Report dated 12/21/98
MedWatch Report dated 1/9/04
Multiple MedWatch Reports dated 9/29/04
MAUDE Database/Report # [redacted]
MAUDE Database/Report # [redacted]

This letter is not intended to be an all inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the Violations identified by the FDA. You also must promptly initiate permanent corrective and preventive action on your quality system.

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. Additionally, no premarket submissions for Class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared or approved until the violations have been corrected. 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction; and/or civil money penalties.

We acknowledge receipt of your letter, dated February 21, 2005, which specifies no real corrective action but only promises substantive corrective action within sixty (60) days. To date, The FDA has received no correspondence from your firm stipulating corrective action as a result of our inspectional observations.

The FDA requests your presence at a meeting at Philadelphia District office on June 30, 2005 at 1:00 P.M. to discuss the content of this letter and the regulatory status of your firm. At that time, please be prepared to discuss in detail the corrective actions you intend to take in order to bring you firm into compliance and prevent the recurrence of similar violations. You should also provide the timetable necessary for implementation of your corrective actions. Please contact Compliance Officer James Illuminati of the FDA Philadelphia District at 215-597-4390 X4402 immediately if you have a conflict with the above referenced date and time for this regulatory meeting.

Additionally, if a substantive written response to this letter is not provided at the scheduled regulatory meeting, it will be necessary to provide this office in writing within fifteen (15) 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 prevent the recurrence of similar violations. 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.

You should respond to James C. Illuminati, Compliance Officer, Food and Drug Administration, Philadelphia District Office, RM904 HFR-CE140, 2nd and Chestnut St, Philadelphia, Pennsylvania, 19106. If you have any questions about the contents of this letter please contact James C. Illuminati at 215-597-4390 x4402 and FAX 215-597-212.

Sincerely yours,


Thomas D. Gardine
District Director
Philadelphia District