| Public Health Service Food and Drug Administration |
| 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4401 |
Department of Health and Human Services
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
February 1, 2011
WL: 23-11
Mr. Richard T. Mastroleo
Owner
Tra & Accessories
449 W. Allen Ave. STE 107
San Dimas, CA 91773
Dear Mr. Mastroleo:
During an inspection of your firm located in San Dimas, California on September 08, 2010 through September 27, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer (specification developer, repacker/relabeler) of Tono-Pen Tonometer Tip Covers, intended to be used in conjunction with the Tono-Pen Tonometer, which is intended to be used to measure intraocular pressure and in the diagnosis of glaucoma. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (“the Act”) [21 United States Code (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.
Our inspection revealed that your 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 establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 C.F.R. 820.30(a). For example, you, being the 510(k) holder and manufacturer (specification developer, repacker/relabeler) of the class II Tono-Pen Tonometer Tip Cover device, are required to comply with applicable design control requirements of the Quality System Regulation, specifically 21 C.F.R. 820.30. However, you have no written design control procedures to control the design of the Tono-Pen Tonometer Tip Covers, including not having documentation for design input, complete design output, design review, design verification, design validation, and design changes. In addition, you do not have a design history file. The inspection revealed that the “blue print” drawing for the Tono-Pen Tonometer Tip Cover device is the only design document you maintain.
2. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a). For example, you did not establish a purchasing control procedure or quality requirements that must be met by your suppliers, including the supplier of Tono-Pen Tonometer Tip Covers, Profound Rubber Industries. There are no quality documents or agreements pertaining to your qualification of Profound Rubber Industries.
3. Failure to establish and maintain procedures to adequately control environmental conditions where these conditions could reasonably be expected to have an adverse effect on product quality, as required by 21 C.F.R. 820.70(c). For example, the Tono-Pen Tonometer Tip Covers are exposed to the uncontrolled warehouse environment during receiving and repackaging.
4. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 C.F.R. 820.80(b). For example, you did not establish criteria for the incoming acceptance of Tono-Pen Tonometer Tip Covers, including establishing a sampling plan based on a valid statistical rationale.
5. Failure to ensure that all equipment used in the manufacturing process meets specified requirements, as required by 21 C.F.R. 820.70(g). For example, you failed to establish maintenance schedules or perform maintenance and calibration activities for the “Autobag” heat sealer used to seal packages containing the Tono-Pen Tonometer Tip Covers that are labeled “Sanitized.”
Our inspection also revealed that the Tono-Pen Tonometer Tip Covers are misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)] in that you failed or refused to furnish any 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. 803 - Medical Device Reporting (MDR) regulation.
Specifically, you failed to develop, maintain, and implement written MDR procedures, as required by 21 C.F.R. 803.17.
Our inspection also revealed that the Tono-Pen Tonometer Tip Covers are adulterated within the meaning of section 501(f)(1)(B) of the Act [21 U.S.C. § 351(f)(1)(B)] because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act [21 U.S.C. § 360e(a)] or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act [21 U.S.C. § 360j(g)]. The device is also misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)] because you did not notify the agency of your intent to introduce the device into commercial distribution and that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k) [21 U.S.C. § 360(k)] and 21 C.F.R. 807.81(a)(3)(i), respectively. For a device requiring premarket approval, the notification required by section 510(k) of the Act [21 U.S.C. § 360(k)] is deemed satisfied when a PMA is pending before the FDA under 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Specifically, the Tono-Pen Tonometer Tip Covers were cleared via K033146, which indicates that the devices will be subject to radiation sterilization (25kGy) and be labeled “Sanitized.” The current inspection revealed that you have not sterilized, nor sanitized your Tono-Pen Tonometer Tip Covers prior to distribution. Your elimination of the sterilization process is a major process change from your original premarket clearance submission that can significantly affect the safety and effectiveness of the device, and thus requires a new 510(k).
Our inspection also revealed that the Tono-Pen Tonometer Tip Covers are misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)] in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act [21 U.S.C. § 360]; were not included in a list required by section 510(j) of the Act [21 U.S.C. § 360(j)]; or a notice or other information respecting the devices were not provided to the FDA as required by section 510(k) of the Act [21 U.S.C. § 360(k)].
Specifically, you have not registered your facility and you have not listed your marketed devices, as required by 21 C.F.R. 807.20(a).
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 (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 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.
Refer to CMS-137970 when replying to this letter.
Your response should be sent to:
Blake Bevill
Director, Compliance Branch
US Food & Drug Administration
19701 Fairchild
Irvine, CA 92612-2446
If you have any questions about the content of this letter please contact: Mei-Chen (Jessica) Mu at 949-608-4477.
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 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 violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Alonza E. Cruse, District Director
Los Angeles District
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