Inspections, Compliance, Enforcement, and Criminal Investigations
Surgical Appliance Industries 04-Apr-05
Department of Health and Human Services
Public Health Service
Cincinnati District Office
April 4, 2005
VIA FEDERAL EXPRESS
Mr. Leslie T. Applegate
Surgical Appliance Industries
3960 Rosslyn Drive
Cincinnati, OH 45209-1110
Dear Mr. Applegate:
During an inspection of your establishment located at 3960 Rosslyn Drive, Cincinnati, Ohio, on October 4-6, 12 & 13, and December 8, 2004, our investigator determined that your firm manufactures medical support stockings. Medical support stockings are medical devices as defined in section 241(h) of the Federal Food, Drug and Cosmetic Act (the Act). See 21 CFR 880.5780.
The above stated inspection revealed that these devices are adulterated under 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 conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices, which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations, Part 820. Significant deviations include, but are not limited to, the following:
1 . Failure to document the acceptance or rejection activities for finished devices. [21 CFR 820.80(d)] Specifically, for 190 of the 253 working days, no compression testing was performed on the compression garments. We acknowledge your response dated November 29, 2004, which included a copy of procedure SAI-1015a, which you have implemented to assure your firm performs finished device testing and documents the acceptance/rejection of these devices. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard to this violation.
2. Failure to evaluate and investigate non-conforming product. [21 CFR 820.90(a)] Specifically: a) There were 5 compression test records for 5 different days that were out of specification; b) There were three compression test records that showed the compression testing machine malfunctioned; c) Between October 4 and 6, 2004, the sewing machines used to manufacture the compression garments required "QC shut off', 24, 27, and 25 times, respectively. Your firm did not perform any re-tests, did not document and trend the non-conformances, nor did you quarantine the products . We acknowledge your response dated November 29, 2004, which includes procedure SAI-1033, which requires that all machine malfunctions be documented and devices retested. Your response states that you are still in the process of establishing a policy and a procedure for using a statistical analysis to trend these non-conformances.
3. Failure of your procedures to completely address the identification, documentation, evaluation, segregation, disposition and investigation of non-conforming product. [21 CFR 820 .90(a)] Specifically, your "control and disposition of non-conforming product" procedures do not address documenting and investigating non-conformances . We acknowledge your response dated November 29, 2004, which included a copy of the new procedures SAI-1015a and SAI-1033, which you have implemented to assure in-process and finished device non-conformances are identified, documented, evaluated, segregated, investigated and have the appropriate disposition. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard to this violation.
4. Failure to establish procedures to ensure the device history records for each batch or lot are maintained to demonstrate the device is manufactured in accordance with the device master records and the requirements of this 21 CFR Part 820. The device history record must include the dates of manufacturing, quantity manufactured, quantity released for distribution, primary identification label and labeling used for each production unit and any device identification and control numbers used. [21 CFR 820.184] We acknowledge your response dated November 29, 2004, which included a copy of the new procedures SAI-1015a and SAI 1031, which you have implemented to assure your firm establishes a device history record for all devices manufactured. Your response also states that you are in the process of establishing device master records for all these devices.
5. Failure to document the calibration performed on the compression testing machine. Specifically, the results of the calibration, the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date are not documented. In addition, after the compression test machine malfunctioned during finished device testing, no calibration activity was performed on the machine to determine if the machine was functioning properly . [21 CFR 820.72(b)] We acknowledge your response dated November 29, 2004, which included a copy of procedures SAI-1017, SAI-1030, and SAI-1001, which you have implemented to assure your firm calibrates all machines and equipment used to manufacture and test the devices. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard to this violation.
6. Failure to use statistical techniques to determine the number of stockings that should be tested during incoming and finished device testing. [21 CFR 820.250(a)] We acknowledge your response dated November 29, 2004, which stated that you have established confidence levels for sample quantities . This response did not include a documented rationale for choosing these sample sizes.
7. Failure to establish adequate management control to ensure that an effective quality system has been established and maintained. [21 CFR 820.20] For example,
A quality policy has not been established. [21 CFR 820.20(a)];
A quality plan has not been established [21 CFR 820.20(d)];
Quality system procedures have not been established and/or are incomplete . [21 CFR 820.20(e)] For example, there are no corrective and preventive action procedures, no document control procedures, no complaint handling procedures, and the procedures for controlling the design process and non-conforming product are not complete.
We acknowledge your response dated November 29, 2004, which included a copy of your quality policy, quality plan, management review procedure, design control procedure, and nonconforming product procedures . Your response states that you still need to develop an overall document control procedure. None of your three responses address that your firm does not have a corrective and preventive action procedure.
8. Failure to document the training of personnel. [21 CFR 820.25(b)] Specifically, no quality or manufacturing employees have been trained in the quality procedures . In addition, the Quality Assurance Technician has no records of training on how to perform in-process and finished device testing.
9. Failure to establish procedures for implementing corrective and preventive actions; and failure to document corrective and preventive activities, including analysis of quality data sources, investigations of causes of non-conformances, and implementation of corrective and preventive actions. [21 CFR 820.100]
10. Failure to establish written complaint procedures for receiving, reviewing, and evaluating complaints . [21 CFR 820.198.] We acknowledge your response dated March 1, 2005, which included a copy of your new complaint procedure. We will evaluate the adequacy of this response during the next FDA inspection of your facility. Until then, no further response is necessary with regard to this violation.
11. Failure to establish and maintain complete procedures to control the design of the device in order to ensure that specified design requirements are met. [21 CFR 820.30] Specifically, your "SAI-1018 Policy and Procedure for Style Developments, Existing Style Review, and Engineering Changes to Hosiery Construction/Specifications" does not address inputs, outputs, design reviews, design verification, validation, transfer, design changes, and the design history file. We acknowledge your response dated November 29, 2004, which included a copy of your new design procedure (SAI-1032). This procedure does not adequately address design inputs (including needs of the user), design outputs, design reviews, design verification, design transfer, and design changes.
12. Failure of the design history file for the ladies' sport casual acrylic below-the- knee 10-20 mmHg to demonstrate that the design was developed following the design control requirements of 21 CFR 820. [21 CFR 820.30(j)] Specifically, the design history file does not include a design plan, complete test records, design transfer documentation, complete verification and validation documents, and complete documentation of the approval of the change. We acknowledge your response dated November 29, 2004, which states you are currently reviewing the designs for all styles of medical support stockings. The inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, in that your firm failed to develop written Medical Device Reporting procedures as required by 21 CFR 803.17. Your March 1, 2005 response states that the compliant procedure (SAI-1038) addresses MDRs. This procedure is not adequate in that it does not define an MDR reportable event, it does not list the timeframes for reporting and how to report an event to FDA.
This letter is not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations. The specific violations noted in this letter and in the Inspectional Observations, Form 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 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 award of contracts. Additionally, no premarket applications for Class III devices 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 granted until the violations related to the subject devices have been corrected.
You should continue to take prompt action to correct any and all deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice . These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
We have received your response letters dated October 13 and November 29, 2004 and March 1, 2005. Please notify this office within fifteen (15) working days of the corrective actions you have taken for the deficiencies you have not addressed in previous correspondence. Additionally, please address the steps you will take regarding the corrective actions, which we do not find adequate, that are discussed under the deviations listed in the above paragraphs. For all of the corrective actions that you have already addressed, we will evaluate the adequacy of their implementation during the next FDA inspection. If corrective action cannot be completed within the timeframes specified in your letters, state the reason for the delay and the timeframe within which the corrections will be completed.
Your response should be sent to Ms. Gina Brackett, Compliance Officer, Food and Drug Administration 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions concerning the contents of this letter, you may contact Ms. Brackett at (513) 679-2700, ext. 167, or you may forward a facsimile to her at (513) 679-2773.
Carol A. Heppe