Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
8050 Marshall Drive, Suite 205
Lenexa, Kansas 66214
Telephone: (913) 495-5100
January 10, 2013
RETURN RECEIPT REQUESTED
Mary Anne Auer, President & CEO
Wexford Labs Inc.
325 Leffingwell Ave
Kirkwood, MO 63122
Dear Ms. Auer:
During an inspection of your firm located in Kirkwood, MO on November 27 through December 21, 2012, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures disinfectant products including Wex-Cide 128. Under section 201(h) [21 U.S.C. § 321(h)] of the Federal Food, Drug, and Cosmetic Act (the Act),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 any function of the body.
This inspection revealed your devices are adulterated within the meaning of Section 501(h) [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 Requirements (cGMP) of the Quality System Regulation found at Title 21 Code of Federal Regulations (CFR), Part 820. We received a response from Mary Jo Thierry, Executive Vice President, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish procedures for acceptance criteria as required by 21 CFR 820.80(a). For example, you use returned product in subsequent batches of Wex-Cide 128. Also, you do not have a procedure dictating this activity is acceptable, you do not routinely test the returned product for acceptance prior to use and you have no established acceptance criteria for using returned product in subsequent batches of product. In fact, you have used returned product which failed specifications for ortho-phenylphenol (active disinfecting agent) in a subsequent batch of Wex Cide 128.
We reviewed your firm's response and concluded that it is not adequate because you have not provided justification for your current practice of incorporating returned product into new batches of product.
2. Failure of the device history record to demonstrate the device was manufactured in accordance with the Quality System Regulations as required by 21 CFR 820.184. For example, your device history records for your class 1 devices, including Wex-Cide 128, do not include information such as the dates of manufacture; the quantity of product manufactured; the quantity of product released for distribution; acceptance records showing the device was manufactured in accordance with the device master record; and the primary identification label and labeling. In addition,there is no documentation showing the device history records have been reviewed and approved by appropriate individuals.
We reviewed your firm's response and concluded that it is not adequate because while you state device history records will have an area to be signed indicating review and approval by appropriate personnel, you do not specify what training or qualifications are necessary for performing the above stated duties. Also, you indicate device history records will contain a range of batch volume variability but you have not indicated how this range of variability was determined or if the range is validated.
3. Failure to establish quality system procedures and instructions as required by 21 CFR 820.20(e).
For example, you do not have adequate written quality procedures for the following:
• Document control
• Complaint handling
• Medical Device Reporting
• Nonconformance handling, documentation and investigation
• Corrective and Preventative Actions (CAPA)
• Product Returns
• Rework and Salvage Operations
• Incoming, in-process, and final acceptance of products
We reviewed your firm's response and concluded that it appears adequate, but will need verification during future inspections.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to: Kansas City District Office at the above address. Refer to KAN 2013-04 in your reply. If you have any questions about the contents of this letter, please contact: Patrick L. Wisor, Compliance Officer at 913-495-5148 or Patrick.firstname.lastname@example.org
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance
John W. Thorsky
Kansas City District Office