Inspections, Compliance, Enforcement, and Criminal Investigations
Misonix, Inc. 20-Dec-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.0 Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
December 20, 2001
RETURN RECEIPT REQUESTED
Mr. Gary Gelman
President and Chief Executive Officer
1935 New Highway
Farrningdale, New York 11735
Ref. #: DEN-02-08
Dear Mr. Gelman:
On October 3 through 19th, 2001, Investigator Nicholas R. Nance of our office conducted an inspection of [redacted], located at [redacted]. Our investigator determined that your firm manufactures various diagnostic ultrasound transducers and refurbishes diagnostic ultrasound systems and accessories. These are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above stated inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System/Good Manufacturing Practice (QSIGM?) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820. The deviations are as follows:
1. Failure to conduct management reviews to determine the suitability and effectiveness of the quality system, as required by 21 CFR 820.20(c). For example, not all sources of quality data are reviewed, tracked or trended by management, such as Discrepant Material Reports (DMRs) or Corrective/Preventive Action Reports (CARS).
2. Failure to establish and maintain procedures for quality audits to assure
that the quality system is in compliance with the established quality system
requirements and to determine the effectiveness of the quality system and document
the results of the quality audits, as required by 21 CFR 820.22. Reaudits of
deficient matters are not taken. For example, audit
schedules show that various elements of the Quality System have not been audited annually, as required by your standard operating procedures (SOPS). Also, your firm has no evidence of reaudits taken to verify that corrective actions were implemented and effective.
3. Failure to establish procedures for identifying training needs and to ensure
that all personnel are adequately trained to perform their assigned responsibilities,
as required by 21 CFR 820.25(b). For example, review of training records for
employees responsible for testing of products revealed lack of training in the
area of Quality System Regulations or on the quality policy. Training records
lack detailed information, indicating what training was conducted, when the
training was conducted and by whom.
4. Failure to establish and conduct procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30. You design control procedures are either inadequate with respect to design and development planning, design input, design validation, design changes and creation of design history files, or were not followed. For example, Your [redacted] does not include a formal, documenteddesign plan as required by the Quality System Regulations. Also, your procedures do not define the equipment, the protocol to be used or how many probes were to be tested in order to establish a successful validation.
5. Failure to establish and maintain adequate procedures for implementing corrective
and preventive actions to include all sources of quality data, as required by
21 CFR 820.100(a)(1), or to investigate the cause of nonconformities relating
to product, processes,
and the quality system, as required by 21 CFR 820.100(a)(2). For example, review of your Corrective and Preventive Action (CAPA) system revealed that your firm only tracks and analyzes complaints to identify existing product and quality problems. Information
contained in Return Material Authorizations (RMAs) is not always evaluated and reviewed as complaints. There are no procedures or criteria requiring RMAs be evaluated for failure investigation, nor are they tracked or trended. Also, in-process defects are not always
documented, investigated or tracked to: identify existing or potential causes of non-conforming product or other quality problems. Test equipment failures, test failures and Discrepant Material Reports are not captured, evaluated or trended.
6. Failure to establish adequate CAPA procedures in that your procedures lack
verification or validation to ensure that such action is effective and does
not adversely affect the finished device, as required by 21 CFR 820,100(a)(4).
For example, several Corrective/Preventive Action reports were found lacking
an effectiveness review, as required by your form.
7. Failure to establish and maintain adequate procedures to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be reported under the Medical Device Reporting (MDR) regulations, as required by 21 CFR 820.198(a)(3). F or example, there is no evidence that complaints or RIVfAs are evaluated or have enough information to allow for evaluation of MDR reporting.
8. Failure to establish and maintain finished device acceptance procedures
to assure that finished devices meet acceptance criteria, as required by 21
CFR 820.80(d). For example, Sonora failed to adequately conduct a quality review
of the device history records in that devices with incomplete and incorrect
records were approved and released for distribution. Procedures do not contain
sufficient information or criteria to define when devices pass inspection, i.e.
test techs performing [redacted] use subjective visual evaluation
of the test results to determine when a probe passes or fails.
9. Failure to establish and maintain procedures to ensure that equipment is
routinely calibrated, inspected, checked and maintained, as required by 21 CFR
820.72(a). For example, records reviewed for test equipment used in the manufacture
of probes were found to either not be on a calibration schedule, showed no evidence
of calibration or had not been calibrated within
the timeframes required by your procedures.
10. Failure to develop adequate validation procedures to assure specified requirements are met, as required by 21 CFR 820.75(a). For example, there is no approved validation protocol to justify the validation test report for the automated [redacted] the automated [redacted] temperature tester. Also, there was no evidence that the [redacted] and the work instructions for testing probe surface temperature have been validated.
The above identified deviations are not intended to be an all-inclusive list
of deficiencies at your facility. It is your responsibility to ensure that your
establishment is in compliance with all requirements of the Federal regulations.
The specific violations noted in this letter and in the Form FDA-483 issued
at the conclusion of the inspection may be symptomatic of serious underlying
problems in your establishments quality system. A copy of the FDA-483
is enclosed for your information. 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 awkd of contracts. Additionally, no premarltet submissions for Class III devices to which the QS/GMP deficiencies are reasonably related will be cleared until the violations are 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 us without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
You should notify this office in writing wlthin fifteen (15) working days of
receipt of this letter of any other additional steps you have taken to correct
the noted violations and to prevent their recurrence. If corrective action cannot
be completed within fifteen (15) working days, state the reason for the delay
and the time within which the corrections will be completed.
Your response should be, sent to Regina A. Barrell Compliance Officer, Food and Drug Administration, Denver District, P.O. Box 25087, Denver, CO 80225-0087. If you have any fiu-ther questions, please feel free to contact Ms. Barrell at (303) 236-3043.
Thomas A. Allison