Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Measurements, Inc. 22-Mar-04
Department of Health and Human Services
Public Health Service
March 22, 2004
RETURN RECEIPT REQUESTED
Mr. William Sones
Medical Measurements, Inc.
53 Main Street
Hackensack, New Jersey 07601
File No: # 04-NWJ-08
Dear Mr. Sones:
During February 5 -12, 2004, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your manufacturing and distribution operations located at the above address. This inspection revealed that you manufacture and distribute Rectal Suction Biospy Tools, which are Class II medical devices under sections 201(h) and 513(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection revealed that your 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, the manufacture, packing, storage, or installation are
not in conformity with the Current Good Manufacturing Practice (CGMP) requirements
of the Quality System Regulations (QSR), as specified in Title 21 of the Code
of Federal Regulations (CFR) Part 820. Significant deviations include, but are
not limited to the following:
1. Failure to establish procedures for implementing corrective and preventive actions (CAPA), as required by 21 CFR 820.100. The document referencing CAPA activities, included in your Quality Manual, describes the review of nonconforming products, services/repairs and complaints, but this document is not followed and does not identify all quality factors required for CAPA evaluation. Specifically, your CAPA system fails to evaluate the following quality factors:
quality audit reports, acceptance activities and purchasing controls;
investigating the cause of nonconformities;
verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
2. Failure to establish complaint handling procedures that ensures all complaints received are reviewed and evaluated, as required by 21 CFR 820.198. Specifically,
your firm has received complaints via electronic e-mail, but these complaints were not transposed to your complaint document form and were not reviewed or evaluated;
returned Rectal Suction Biospy units are not evaluated as potential product complaints, even when the events describe units with quality related problems, such as failure to cut, cutting trigger would not release, and capsule not working with cutter.
3. Failure to establish written procedures for servicing devices, as required
by 21 CFR 820.200. Specifically, there is no documentation that returned units
serviced or repaired by your fum have been tested and conform to their original specifications.
4. Failure to establish and implement an effective quality system that is maintained at all levels, as required by 21 CFR 820.20. Specifically,
your firm has not established and/or maintained a quality policy to ensure that medical devices manufactured and distributed by your firm comply with all quality system requirements;
there is no evidence that management reviews of your quality system are conducted and evaluated.
5. Failure to establish and conduct quality audits as required by 21 CFR 820.22.
Specifically, the document referencing Quality Audits, included in your Quality
Manual, does not identify objectives or criteria for conducting quality audits.
Furthermore, this document states quality audits will be conducted every six
months. There is no evidence that quality audits have been performed as required.
6. Failure to establish purchasing control procedures to ensure the received products and services conform to specifications, as required by 21 CFR 820.50. Specifically, your procedure entitled "Purchasing-Inspection-Sale Cycle for [redacted] Rectal Suction Biopsy Tools contains instructions for inspecting incoming units, but there are no documented purchasing controls to determine if suppliers and contractors used by your firm conform to your device specifications.
7. Failure to establish and maintain procedures for the identification, documentation,
validation or, where appropriate, verification, review and approval of design
changes before their implementation, as required by 21 CFR 820.30. Your Quality
Manual does not address design controls, which are required for Class II devices.
Additionally, the above-stated inspection revealed that your device is misbranded under section 502(t)(2) of the Act, in that your firm failed to establish and implement written medical device reporting (MDR) procedures, as required by 21 CFR 803.17. Your customer compliant document does not adequately address the requirements for evaluating, investigating and reporting reports of death, injuries or malfunctions that may be MDR reportable events.
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 the regulations promulgated under it. Federal agencies are routinely advised of Warning Letters issued so that they may take this information into account when considering the award of government contracts. The specific violations noted in this letter and in the FDA 483 issued to you at the close of the inspection may be symptomatic of serious underlying problems in your firms manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by FDA.
You should take prompt action to correct these deviations. Failure to implement
corrective measure may result in further regulatory action initiated by FDA
without further notice. These actions include, but are not limited to seizure,
injunction and/or civil penalties. We have received your written response, dated
February 23, 2004 and your interim action plan given to the investigator during
the close-out of the inspection. Your response and interim plan are inadequate.
While your response promises correction, it fails to include specifics on how
such action will be accomplished. Furthermore, several inspectional observations
concerning complaint handling, overall quality system deficiencies and lack
of quality audits, were previously cited during the April 2000 inspection, indicating
that your prior commitments have been ineffective. Your current corrective action
plan needs to adequately address QSR requirements applicable to your operations
and prevent recurrence of similar deficiencies.
You should notify this office in writing within fifteen (15) working days of receipt of this letter describing the specific steps you have taken, or intend to take, to prevent the recurrence of similar violations. Please include any and all documentation to demonstrate that adequate correction has been achieved. Your written response should be addressed to the Food and Drug Administration, New Jersey District Offrce, 10 Waterview Blvd., 3rd Fl, Parsippanr, New Jersey 07054, Attn: Mercedes Mota, Compliance Officer.
Douglas I. Elssworth
New Jersey District Office