- TreyMed, Inc.
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100
FAX: (612) 334-4142
January 9, 2015
Via UPS Overnight Delivery
Refer to MIN 15 – 06
Robert H. Ricciardelli
N56 W24790 North Corporate Circle, Suite C
Sussex, Wisconsin 53089-4378
Dear Mr. Ricciardelli:
During an inspection of your firm located in Sussex, Wisconsin, on October 7 through October 21, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm contract manufactures a Class II medical device marketed as “(b)(4) Sensor” and “(b)(4) Sensor.” 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 any 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 regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received your firm’s responses to the Form FDA 483 (FDA 483) dated November 7 and December 16, 2014, and our evaluation is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
(1) You failed to adequately establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example:
A. Your firm failed to follow your written procedure “Nonconforming Material SOP,” Document No. 200-0007, in that 5 out of 5 “Nonconforming Material Reports” (NMRs) reviewed during this inspection lack a determination of whether an investigation is required (step (b)(4)) and also lack the disposition authority of the nonconforming material (step (b)(4)).
B. NMR 140416A, dated 4/11/14, indicates “Rework” to be performed for (b)(4) adult airway adapters (Lot CO-01) that were rejected due to “(b)(4).” However, there is no documented evidence of the rework instructions and there is no evidence to support the disposition of “rework” for the nonconforming airway adapters. The final disposition status is unknown.
C. The “Receiving Inspection and Testing SOP,” Document No. 200-0006, step (b)(4) states: “Rejected shipments shall be handled per the ‘Nonconforming Materials SOP.’”
However, Lot number CP-02 of adult airway adapters, part number (b)(4), was tested for (b)(4) on 2/26/14 and appears to have resulted in failures as the initial entry indicates (b)(4) parts were rejected. On 3/3/14, the entries were modified to indicate there were no rejects and the lot was acceptable. Your firm failed to initiate an NMR for the initial test failures, and an entry on the “Sample Inspection Data” record indicates “(b)(4) ok to use***.” These adapters were released for use in production.
Additionally, the incoming inspection performed on adult airway adapters, Lot CP-03 (Part number (b)(4)), was accepted on 4/11/14. However, the “Sample Inspection Data” record for this lot (dated 4/10/14) has an entry for (b)(4) Test as “Fail” for the first (b)(4) samples tested, with a status of “Accept.” There is no evidence that your firm initiated an NMR for these test failures. Further, your firm lacks documented rationale for accepting the nonconforming adapters. These adapters were released for use in production.
(2) Your device history record does not demonstrate that the device was manufactured in accordance with the device master record, as required by 21 CFR 820.184. Specifically, your firm failed to follow your written procedure “Shop Order SOP,” Document No. 200-0017, which defines the means by which unique lot or batch numbers are assigned and production history information is accumulated for the device history record (DHR). The following examples are deficiencies that were observed during a review of DHRs:
A. Your procedure requires a “Line Setup/Clearance (LSC)” form which indicates all pertinent drawings, Bill of Materials (BOM), Work Instructions, and any special instructions used in such assembly. This record was not present in the documentation for (b)(4) Sensor or (b)(4) Sensor manufacturing orders (MOs) 2091, 2041, 2039, 1981/2015, 1730, and 1387.
B. The BOM for Lots E0614 (manufacture date 5/14/14) and E0814 (manufacture date 8/21/14) identifies Rev. 1 of the airway adapter, (b)(4). However, Rev. 2, dated 1/21/14, was in effect at the time of production.
C. The BOM for Lot E0814 identifies Rev. 5 of the assembly work instructions (310-0038-5) as being followed for 3 of 6 BOMs; manufacturing commenced on 9/15/14, 9/12/14, and 9/20/14. However, Rev. 5 was not approved/effective until 9/24/14.
D. The signed BOM for Lot U13381 (MO 1730) identifies Work Instruction 310-0090, Rev. 0, and Packaging Instruction 310-0094, Rev. 0, as being followed for the production of (b)(4) Sensor. However, review of the DHR revealed that an unapproved Work Instruction (310-0089) and Packaging Instruction (310-0093) were followed. The products were approved, released, and shipped on 9/25/13.
E. The signed BOM lists the quantity manufactured for Lot U13381 as (b)(4). However, there were (b)(4) test results for (b)(4). The disposition of the other (b)(4) devices is unknown.
F. The quantities manufactured and recorded on the BOMs reviewed during the inspection are discrepant. The actual number of devices manufactured and distributed is unknown.
G. Step (b)(4) of the procedure states when all tasks are completed, a review by both Manufacturing and QA is to be performed in order to release the finished goods. However, finished goods were released prior to completion of this review for Manufacturing Orders 2039 and 2041.
(3) Your device master record has not been adequately maintained, as required by 21 CFR 820.181. Specifically, you maintain two separate Device Master Records (DMR): one for the (b)(4) Sensor and one for the (b)(4) Sensor. However, the BOM included in your current (b)(4) DMR does not identify the correct revisions of the drawings for the airway adapter and 9 inch tubing with an expander. Additionally, neither DMR includes or references the quality assurance procedures and specifications, including acceptance criteria and the quality assurance equipment used.
(4) You failed to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm failed to follow your written procedure “Receiving Inspection and Testing SOP,” Document No. 200-0006. Step (b)(4) of the procedure requires the incoming inspection to be performed using a current revision for the drawing or specification.
However, on 2/24/14, 2/26/14, and 4/11/14, your firm performed an incoming inspection of adult airway adapters (lots CP-01, CP-02, and CP-03) following Rev. 1 of the drawing for Part No. (b)(4). The drawing revision in effect at the time of these incoming inspections was Rev. 2, effective 1/21/14. This revision included a change to (b)(4). Additionally, on 7/31/13, your firm performed an incoming inspection of triple tubing used on the (b)(4) Sensor (Lot CO-02) following an incorrect specification criteria of (b)(4)” per your internal “Sample Inspection Data” record. The drawing for the triple tubing (621-0021, Rev. 1) specifies the length as (b)(4)”.
(5) You failed to adequately establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your procedure lacks a requirement to verify or validate the corrective and preventive action to ensure the action is effective and does not adversely affect the finished device.
We have reviewed your responses dated November 7 and December 16, 2014. You have identified the need for additional training, and have committed to providing such training through a third party cGMP consultant. Additionally, you have committed to completing a retrospective review of your nonconforming material reports executed in 2014 and CAPAs closed in 2014 to be conducted in conjunction with your third party cGMP consultants. You have also committed to review the “Nonconforming Material SOP,” Device History Record documentation, Device Master Records, incoming and customer release specifications, and the Corrective/Preventive Action procedure to determine the need for improvement. FDA will need to conduct a follow-up inspection to evaluate the adequacy of those reported corrective actions.
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 15 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 15 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 Melissa I. Michurski, Compliance Officer, at the address on the letterhead. If you have any questions about the content of this letter please contact Ms. Michurski at (612) 758-7185.
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.
Michael Dutcher, DVM
Close Out Letter