| Public Health Service Food and Drug Administration |
Kansas City District |
Department of Health and Human Services
January 24, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2011-04
Douglas B. Peavey
President
Lynn Peavey Company
10749 W. 84th Terrace
Lenexa, KS, 66214-3612, USA
Dear Mr. Peavey:
During an inspection of your firm located in Lenexa, KS on September 15, 2010 through September 21,2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Lynn Peavey Sexual Assault Evidence Collection Kit and the Lynn Peavey Blood Alcohol Collection Kit. 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 are intended 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 (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
For example, your firm's procedure No (b)(4): "Corrective and Preventive Action Procedure (CAPA)" does not include requirements for analyzing quality audit reports, quality records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; investigating the cause of nonconformities; identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; verifying or validating the corrective and preventive action; implementing and recording changes in methods and procedures; ensuring that information related to quality problems is disseminated to those directly responsible for assuring the quality of affected products; and submitting relevant information for management review.
2. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements including quality requirements, as required by 21 CFR 820.50(a)(1).
For example, supplier evaluations documenting the selection of suppliers on the basis of their ability to meet specified requirements were not available for review and reportedly do not exist for the Sexual Assault Evidence Collection Kit and the Blood Alcohol Collection Kit.
3. Failure to establish and maintain procedures for acceptance of incoming products, as required by 21 CFR 820.80(b).
For example, your firm has not established and maintained procedures for performing incoming inspections, tests, or other verification activities to confirm components of your firm's convenience kits meet specified requirements. No incoming acceptance criteria exist for and no incoming inspection, test or other verification activity is conducted on the (b)(4) included in the Sexual Assault Evidence Collection Kit. The (b)(4) are used to collect blood for DNA analysis. Similarly, no incoming acceptance criteria exist for and no incoming inspection, test or other verification activity is conducted on the safety capped needles included in the Blood Alcohol Collection Kit. The safety capped needles are used to collect blood. These products are placed on shelves and available for production use as soon as they are received.
4. Failure to maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j).
For example, your firm was not able to provide a DHF containing or referencing records necessary to demonstrate that the Blood Alcohol Collection Kit (a class II device) design was developed in accordance with an approved design plan and the requirements of 21 CFR 820. The only available document related to the design of this kit is the bill of material.
5. Failure to establish and maintain procedures to control documents required by 21 CFR Part 820, as required by 21 CFR 820.40.
For example, your firm has not established document control procedures that provide for: document review (for adequacy), approval and distribution; the documentation of the approval, including the date and signature of the individual(s) approving the document; and, document change control.
6. Failure to establish 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).
For example, your firm does not maintain a standard operating procedure for identifying personnel training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities with regard to the manufacturing of regulated medical devices including the Sexual Assault Evidence Collection Kit and the Blood Alcohol Collection Kit. According to a document entitled: "Sexual Assault Assembly Certification" dated (b)(4). (b)(4) team members were certified to assemble Sexual Assault Evidence Collection Kits, but the uncontrolled document does not identify the training needs necessary for this certification.
7. Failure to maintain a device master record (DMR), as required by 21 CFR 820.181.
For example, your firm does not have a device master record for the Blood Alcohol Collection Kit (a class II device) even though your firm has been manufacturing this kit since (b)(4).
8. Failure to adequately write sampling plans that are based on a valid statistical rationale, as required by 21 CFR 820.250(b).
For example, your firm has no valid statistical rationale for the sampling plans used to select samples used during finished device acceptance activities relating to the Sexual Assault Evidence Collection Kit or the Blood Alcohol Collection Kit.
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 C.F.R. Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), 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: Amy E. Devine, Compliance Officer, U.S. Food and Drug Administration, Kansas City District, 11630 West 80th Street, Lenexa, Kansas 66214-3340. If you have any questions about the content of this letter, please contact Compliance Officer Devine at 913-752-2719.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (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 violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Sincerely yours,
/s/
John W. Thorsky
District Director
Kansas City District Office
No comments:
Post a Comment