Inspections, Compliance, Enforcement, and Criminal Investigations
MCT Medical Products 09-Dec-05
Department of Health and Human Services
Public Health Service
December 9, 2005
RETURNED RECEIPT REQUESTED
Mr. Matthew A. Alanis, Owner
MCT Medical Products
6047 Wood Pass
San Antonio, TX 78249
Dear Mr. Alanis:
During an inspection of your establishment located in San Antonio,Texas, on October 12 through 20, 2005, our investigator determined that your, firm is an importer and domestic distributor of. sphygmomanometers. (non-automated blood pressure measurement devices) and other medical products. The sphygmomanometer is a device as defined by section 201.(h) of the Federal Food, Drug, and Cosmetic Act (the Act) 21 U.S.C. § 321(h).
Our inspection documented that your firm purchased sphygmomanometers from a domestic device manufacturer and inspected them. If the sphygmomanometers are out-of-calibration, your firm adjusted or replaced the pressure gauges of the affected sphygmomanometers via a rework process. Your firm failed to ensure that the reworked sphygmomanometers are correctly calibrated after rework. Inspection, adjustment or replacement of the pressure gauges is considered a step in the manufacturing process of these sphygmomanometers. In doing so, your firm is a manufacturer of medical devices. See 21 CFR 820.3(o).
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)) because the methods used in, or the facilities or controls used for the manufacturing, packing, labeling, storage, installation or servicing are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
At the close of the inspection, you were issued a List of Inspectional Observations, Form FDA483, which identified a number of significant QS Regulation violations including, but not limited to, those described below.
1. Your firm failed to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to ensure that all the requirements of 21 CFR 820.198(a) through (e) are met [FDA-483 Item 1]. Specifically, your firm has not maintained a complaint file to document and investigate oral complaints received or the nature of the returned devices from unsatisfied customers in the past three years.
2. Your firm failed to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2) [FDA-483 Item 4]. Specifically, your firm reset the needle of the pressure gauges (needle zeroing) or replaced the pressure gauges of the out-of-calibration sphygmomanometers without establishing specific calibrating or testing procedures or following specific recognized standards to ensure that reworked sphygmomanometers are correctly calibrated after rework. Additionally, you failed to maintain records of reworked sphygmomanometers. Information provided by the domestic manufacturer indicated that zeroing, the needles does not guarantee the pressure gauge is calibrated or the calibration of the replacement gauges has to be verified against a calibrated mercury sphygmomanometers.
3. Your firm failed to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR 820.80(b) (FDA-483 Item 2]. Specifically, your firm has not established written procedures for the testing, inspection or verification of incoming sphygmomanometers received from the domestic device manufacturer. All acceptance inspection and acceptance criteria were verbal in nature and were not documented. Additionally, there is no acceptance record showing the quantity received and inspected for acceptance or rejection.
4. Your firm failed to ensure that information related to quality problems or nonconforming product is documented and disseminated to those directly responsible for .assuring the quality of such product or the prevention of such problems, as required by 21 CFR 820.100(a)(6) and 820.100(b) [FDA-483 Item 7). Specifically, your firm requested the adjustment tool or new pressure gauges from the domestic device manufacturer in order to reset or replace the out-of-calibration pressure gauges. You did not document your conversation with the domestic device manufacturer concerning the quality of the sphygmomanometers you received.
5. Your firm failed to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2) [FDA-483 Item 6]. Specifically, your firm did not investigate the root cause of the out-of-calibration sphygmomanometers received from the domestic device manufacturer.
6. Your firm failed to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, including evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50 [FDA-483 Item 3]. Specifically, your firm failed to establish and document expected quality requirements for the sphygmomanometers purchased from the domestic device manufacturer.
Should your firm choose to discontinue performing manufacturing operations to the sphygmomanometers you receive, your firm is advised to comply with the complaint handling requirements in 21 CFR 820.198 and MDR reporting requirements in 21 CFR 803 applicable to importers of foreign manufactured devices. Importers are classified as manufacturers subject to 21 CFR 820 Quality System Regulation for the operations they perform. See 21 CFR 820.3(o).
Regarding your shipment of the imported sphygmomanometers that was detained by FDA's Southwest Import District (SWID) due to the devices failure to meet FDA's testing, please contact SWID Compliance Officer Catherine Vieweg at (214) 253-5288 to discuss and arrange the disposition of these imported sphygmomanometers.
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. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
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 applications for premarket approval to which the Quality System regulation deficiencies are reasonably related will be 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 violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take, to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
Michael A. Chapell
Dallas District Director