Inspections, Compliance, Enforcement, and Criminal Investigations
Quality Aspirators, Inc. 23-May-06
Department of Health and Human Services
Public Health Service
May 23, 2006
RETURNED RECEIPT REQUESTED
Mr. Corless W. Wiley, President
Quality Aspirators, Inc.
1419 Godwin Lane
Duncanville, Texas 75116-2452
Dear Mr. Wiley:
Between March 29 and April 11, 2006, the United States Food and Drug Administration (FDA) conducted an inspection of your establishment at the above-referenced address. The FDA investigator determined that your firm manufactures and distributes dental and surgical aspirators, loupes with or without the clip-on headlight, suction valves and accessories, irrigators with or without suction, cleaning brushes, A-C powered light sources, and disposable aerosol reduction systems (SafetySuction™). These products are devices, as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 321(h)).
The FDA's 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, storage, or installation 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, FDA issued to your firm a list of Inspectional Observations, Form FDA-483 (copy enclosed), which identifies a number of significant violations, including, but not limited to, those described below.
1. Failure to implement and record changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR § 820.100(a)(5). FDA-483 Item 2. For example, between 2004 and 2006, your firm received (37) complaints of loupe hinges breaking and subsequently initiated two corrective action requests to address the quality problem. In the first corrective action request [CAR #162] initiated on September 16, 2005, your firm identified that a mold design change of the loupes would correct the quality problem. This corrective action was not implemented. In a second corrective action request [CAR #165] initiated on March 2, 2006, your firm identified that a design weakness in the loupes hinges was the root cause of this recurring quality problem and planned a redesign. However, neither corrective action has been implemented at the time of the inspection. Your firm continues to send product replacements and record complaints.
2. Failure to adequately analyze 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, as required by 21 CFR § 820.1 00(a)(1), and document the results of analysis, as required by 21 CFR § 820.100(b). FDA-483 Item 5. For example, your firm has not conducted and documented an analysis of production rejects (e.g. in-process nonconforming device components or finished devices, scrapped materials). Your General Manager stated that your firm had analyzed (reviewed) the trends of complaints received but had not documented the results of its analysis.
3. Failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR § 820.80(a). [FDA-483 Items 7 and 9]. For example:
a. Although your employees were verbally instructed which measurement equipment to use and which dimensions of the device components to measure (e.g. bone tack cap, bone tamper, bone scraper), your firm does not have written procedures for the final measurement and inspection of these products.
b. Regarding the assembly of loupes, your firm has no written procedures for determining how much [redacted] is to be used in the "workabilityluseability" test, how [redacted] must be, and what action to take if the product fails the "workabilityluseability" test.
4. Failure to establish and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR § 820.75(b), and failure to validate a process whose results cannot be fully verified by subsequent inspection and test, approve the validation according to established procedures, and document the validation activities and results, as required by 21 CFR 820.75(a). [FDA-483 Item 1]. For example, your firm has not:
a. Evaluated and documented the equipment installation of the [redacted] computerized numerical control machines (CNC) used to mill or drill the dental instrument components to ensure that their operational and performance specifications are met.
b. Validated the milling process, including the software programming of the [redacted] CNC machines, to ensure that the dental instrument component specifications manufactured by these CNC machines are consistently met. Throughout the milling process, the tools and the programming parameters of the CNC machines have to be adjusted or changed depending on your firm's subsequent inspection or testing of the dental instrument components. Changes in tools and programming parameters are not conducted and documented in accordance with any written procedures or instructions. It is noted that your firm did not perform [redacted] inspection or testing of the dental instrument components to help detect variations in component specifications.
5. Failure to establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met, including documentation of the maintenance activities, as required by 21 CFR § 820.70(g)(1). [FDA-483 Item 8]. For example, the operator's manuals of the [redacted] referenced CNS machines specify the [redacted] and [redacted] preventive maintenance that are to be complete. However, your firm had no documentation that these maintenance activities on CNC machines were performed.
6. Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR § 820.198(a), and to ensure that ail the requirements of 21 CFR § 820.198(a) through (e) are met. [FDA-483 Item 4]. For example:
a. Four complaints reviewed did not contain an evaluation (e.g. Complaint #174, 205, 224, and 225).
b. Two complaints reviewed did not document possible corrective actions or an explanation of why there was no corrective action (e.g. Complaint # 143 and 232).
c. Five complaints reviewed did not document an evaluation by your firm's management representative, as required by the complaint form (e.g . Complaint #205, 224, 225, 232, and 236).
d. Three complaints reviewed did not have a signature and completion date by the individual(s) reviewing the complaints (e.g. Complaint #102, 143, and 151).
7. Failure to establish and maintain adequate procedures for identifying training needs and documenting personnel training to ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR § 820.25(b). [FDA-483 Item 10]. Your firm did not document what training courses your employees received, what products they were trained for, or what tasks they were trained to perform. For example:
a. Training documentation of employees conducting internal audits did not document a description of the training courses received or the specific audit areas involved in the training.
b. Training documentation of employees performing final inspections did not document the specific products and their associated final inspection procedures involved in the training.
c. Employees performing milling or drilling operations did not have training documentation.
Responding to This Letter
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.
You must take immediate action to correct all violations of the Act and FDA regulations. Failure to promptly correct your firm's 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.
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 QS 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.
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-D0, 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. Chappell
Dallas District Director