Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Accessories, Inc. 7/30/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4906
RETURN RECEIPT REQUESTED
Mr. Janis G. Ziedonis
Medical Accessories, Inc.
92 Youngs Road
Trenton, NJ 08619
Dear Mr. Ziedonis:
During an inspection of your firm located in Trenton, New Jersey, on April 27 through 30,2009, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures blood pressure cuffs, ultrasonic transducers, tocotonameters, and leg plates. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that these 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, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. You have not responded in writing to our investigators' observations noted on the Form FDA 483, List of Inspectional Observations (FDA-483) that was issued to you on April 30, 2009. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action. 21 C.F.R. § 820.100(a).
Specifically, your firm has no Corrective and Preventive Action (CAPA) procedure that includes requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. For example, you stated during the inspection that your firm has implemented corrective and preventive actions in the past, but you keep no records regarding any such actions performed by your firm. This violation was noted on a previous FDA-483 that was issued to your firm.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. 21 C.F.R. § 820.198(a).
Specifically, your firm has no complaint handling procedures. For example, you stated that your firm has received complaints in the past concerning leaky blood pressure cuffs and non-working transducers and tocotonameters, but your firm handles all complaints verbally and does not maintain any written complaint files.
3. Failure to establish and maintain procedures for acceptance activities. 21 C.F.R. § 820.80.
Specifically, your firm has no written acceptance procedures to ensure that your devices meet their specified requirements. For example, your firm does not document the results of the (b)(4) pressure tests that it performs on blood pressure cuffs to determine whether they have any air leaks.
4. Failure to establish and maintain procedures to control product that does not conform to specified requirements. 21 C.F.R. § 820.90(a).
Specifically, your firm has no procedures to control product that does not conform to specified requirements. For example, you stated that your firm uses a (b)(4) pressure machine to test your blood pressure cuffs for air leaks and that if a product fails the pressure inflation test, you either discard the unit or repair it and test it again. Your firm has no documentation regarding nonconforming units (e.g., those that fail the air leak testing). Furthermore, your firm fails to evaluate and document nonconformance to determine the need for an investigation and/or notification of the persons responsible for the nonconformance.
5. Failure to maintain device master records (DMRs). 21 C.F.R. § 820.181.
Specifically, your firm has not established and maintained DMRs, that include, or refer to the location of the device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods, for its blood pressure cuffs and transducer devices.
6. Failure to maintain device history records (DHRs). 21 C.F.R. § 820.184.
Specifically, your firm has not established and maintained procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that your transducers are manufactured in accordance with the DMR. For example, you did not maintain DHRs for (b)(4) Model 1350 tocotransducers manufactured in October 2008.
Our inspection also revealed that your devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Specifically, your firm has failed to develop, maintain, and implement written MDR procedures. 21 C.F.R. § 803.17. For example, your firm has no system for the timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. This issue was discussed with you during a previous inspection at your firm.
Furthermore, our inspection revealed that you have not registered your facility as a medical device manufacturer. Failure to register a facility with FDA constitutes misbranding under section 502(0) of the Act, 21 U.S.C. § 352(o), in that your devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under Section 510,21 U.S.C. § 360. You can obtain the registration form from our website at http://www.fda.gov.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.
Your response should be sent to: Robert J. Maffei, Compliance Officer, U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054. If you have any questions about the content of this letter, please contact Mr. Maffei at 973-331-4906.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA-483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Diana Amador Toro
New Jersey District Office