Gottfried Medical, Inc.
Dear Mr. Gottfried:
During an inspection of your firm, located in Toledo, OH on March 9 through 24, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of medical support stockings to prevent pooling of blood. 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 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 (CFR), Part 820. We received a response, dated March 27, 2015, from Brian M Genide, CEO concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to you. We address this response in a paragraph after the list of violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically,
Your procedures addressing corrective and preventive actions, “Procedures for Corrective and Preventive Action”, PCPA-00, dated10/5/10 and “Measurement and Analysis” procedure, MA-00, dated 10/5/10, are not adequate in that:
a) Your procedures do not address:
1. Initiating a corrective and preventive action commensurate with the significance and risk of the nonconformity.
2. Verifying and validating corrective and preventive actions to ensure such action is effective and does not adversely affect the finished device.
3. Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems.
b) Data sources, such as complaints, warranty returns, and repairs/adjustments, are not being analyzed using appropriate statistical methodology.
For example, on a quarterly basis your Director of Operations is recording the number of adjustments, repairs and warranty returns during this time period but no analysis is being performed.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically,
Your “Customer Inquiries and Complaints” procedure, CIC-00, dated 10/5/10, is not adequate in that:
a) It does not assure that all communications that allege deficiencies related to identity, quality, durability, reliability, safety, effectiveness or performance of the device after it is released for distribution are identified as a complaint. A search of your database used to document “Customer Feedback” for the past 2 years revealed medical stocking that were returned due to broken zippers, sewer errors, and other manufacturing errors were not documented, evaluated and/or investigated as complaints.
b) Your procedure has not been updated to reflect the change that was made in 2011 to document all complaints on a form in your electronic system, and not on the hard copy “Product Inquiry/Complaint form” as required by section 6.3 of your complaint procedure. Additionally, there are no procedures on how to enter data in this electronic system.
c) Section 6.18 of your complaint procedure requires an evaluation of each complaint to determine whether it represents an event which is required to be reported to FDA under part 803, Medical Device Reporting (MDR) be documented. You are not implementing this part of your procedure in that MDR determinations are not being documented.
3. Failure to establish and maintain procedures to control product that does not conform to specified requirements; and 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(a) and (b). Specifically,
You are not implementing your “Control of Non-Conformances” procedure, CNC-00, dated 10/5/10, in that in-process non-conformances are not being documented, evaluated, and investigated. For example:
- During the inspection, the FDA Investigator witnessed an employee performing the final quality inspection flattening stitches on a medical stocking. The employee stated she should send the stocking back to sewing for correction, but to save time she completed the correction. A non-conformance report was not completed and the rework was not documented.
- Your CEO and Director of Operations informed the FDA Investigator that on “occasion”, about twice a month, a medical stocking is “remade”. An example for this rework is the “garment shrank during the dye process”. These nonconformances and reworks are not documented.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specifications, as required by 21 CFR 820.50. Specifically,
Your “Ordering and Receiving Production Material” procedure, ORPM-00, dated 10/5/10, is not adequate in that:
a) It does not address establishing the requirements, including quality requirements, that must be met by suppliers, contactors, and consultants.
b) It does not address the evaluation of suppliers, contractors and consultants on their ability to meet specified requirements, including quality requirements. You have not documented the evaluation of any of your suppliers, including your fabric supplier, yarn supplier, and thread supplier. There are no documented evaluations of suppliers.
c) It does not define the type and extent of control to be exercised over products, services, suppliers, contractors, and consultants based on evaluation results.
d) It does not address establishing, where possible, an agreement that the supplier, contractors, and consultants, agree to notify the manufacturer of changes in the product or service so the manufacturer may determine whether the changes may affect the quality of a finished device. No written agreements have been established with any of your suppliers.
5. Failure to establish and maintain procedure for identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, a sticky note on the “Chaps” instructions sheet stating “No Longer Need F Velcro Lengths” is the only documentation for the change to receive the elastic with the Velcro already sown onto it. This design change did not go through your formal change control as required by “Change Control” procedure, CC-00, dated 10/5/10.
6. Failure to establish and maintain procedures to ensure the device history records (DHR’s) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of part 820, as required by 21 CFR 820.184. Specifically, you do not have a written DHR procedure for your medical stockings.
7. Failure to conduct quality audits by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. For example, your Director of Operations, audited your complaint handling system in 2014, and she is responsible for determining if the “customer feedback” is a complaint.
8. Failure to establish procedures to ensure management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure the quality system satisfies the requirements of 21 CFR Part 820 and the manufacturer’s established quality policy and objectives, as required by 21 CFR 820.20(c). Specifically, your “Management review” procedure, MR-00, dated 10/5/10 states that management review meetings are to be conducted annually. Per your CEO, your firm has not conduct a management review in the past 4 years.
9. Failure to establish and maintain procedures to control all documents that are required by Part 820, as required by 21 CFR 820.40. Specifically, your “Control of Records” procedure, CR-00, dated 10/5/10, does not require the approval, including the date and signature of the individual(s) approving the document, be documented. None of your quality system procedures have approval signatures.
10. Failure to establish and maintain procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25 (b). Specifically, your “Training Program” procedure, TP-00, dated 10/5/10, is not being implemented in that there is no documented training for any of your firm’s employees.
Our inspection also revealed that your devices are misbranded under 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 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm’s “Medical Device Reporting” procedure, MDR-00, dated 10/5/10, does not establish a process that meets the requirements of 21 CFR 803.17.
We cannot determine the adequacy of your response at this time. Your response states that you have hired additional staff to help with FDA compliance. You state that you will be revising your corrective and preventive action, complaint, purchasing control, and MDR procedures. It also states that you will be applying the appropriate statistical methodology to ensure evaluation of all potential data sources; will be creating a non-conformance log; will be generating agreements with suppliers; hired additional personnel so that audits will be conducted by a person not involved in the function being audited; will document management reviews; will identify and document design changes; will be assuring all documents are controlled; and will be creating a procedure to identify training needs, assure personnel are trained, and training is documented. You state that you “expect to make considerable progress in the remaining months in 2015, and expect to correct all deficiencies by March 2016”. Please provide a specific timeframe for the corrective action for each violation listed, as described below.
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 the Food and Drug Administration 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 working days from the date you receive this letter of the specific steps that 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: Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about the content of this letter please contact Ms. Brackett at (513) 679-2700, ext. 2167, or by facsimile at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations 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 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.