Inspections, Compliance, Enforcement, and Criminal Investigations
Gresco Products, Inc. 12/6/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
December 6, 2011
VIA UPS OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
Clinton D. Vaupel, President
Gresco Products, Inc.
13391 Murphy Road
Stafford, TX 77477
Dear Mr. Vaupel:
During an inspection of your firm located in Stafford, Texas, on May 24, 2011, through June 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures dental prosthetics used for restorations. 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 regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received a response from Scott Vaupel, Vice President, dated July 12, 2011, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We reviewed the response and conclude that it is not adequate. Your firm stated that it intended to correct all the deficiencies and that some issues were already corrected. However, your firm did not submit documentation describing the implementation of the correction and the corrective action for each deficiency.
The violations identified at your firm's facility include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm did not establish procedures for implementing corrective and preventive action that include the requirements listed in 21 CFR 820.100.
2. Failure to establish and maintain adequate procedures for finished acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d).
a. The undated Procedure for Product Release Form states that test results and lot numbers should be recorded in the product release form and that the product release form should be signed and dated. However, your firm last recorded the Quality Control tests results on a final release form for Enam-Etch on July 31, 2008, for Oral Ceram-Etch on August 18, 2008, for Oral Met-Etch on August 22, 2007, for Cari-D-Tect on July 2, 2008, and for Prilane on August 23, 2007. According to the product lot journal, your firm manufactured these medical devices from December 04, 2008, to May 24, 2011.
b. Your firm's undated procedure for final release of the Ceram-Etch device did not identify the specific release (acceptance/rejection) criteria for the etch test and pH test. Your firm verbally stated that the pH test for Ceram-Etch was eliminated because the pH meter needed maintenance.
c. Your firm's undated procedure for final release of the Enam-Etch device did not identify the specific release criteria for the etch test and the final release form used for Enam-Etch did not include a field to document the etch test results.
d. Your firm's undated procedure for final release of the Met-Etch device did not identify the specific release criteria for the etch test or pH test and the methodology used in performing the tests. Your firm verbally stated during the inspection that it ceased performing the pH test.
e. Your firm failed to establish procedures for final acceptance activities and failed to use the final product release form for documenting the quality control testing results for the Cirrus alloy device.
3. Failure to adequately establish and maintain procedures for acceptance of incoming products, as required by 21 CFR 820.80(b).
a. Your firm's undated procedure, "Procedure for Identifying Raw Materials," requires that the date received, material name, material manufacturer, lot number, and quantity received be documented in the raw material journal. However, your firm did not log incoming raw materials/chemicals in the raw material journal after October 17, 2007.
b. Your firm's undated procedure, "Procedure for Identifying Raw Materials," lacked the following:
1. Defined method of evaluating whether the incoming product meets the established specification;
2. Defined method for documenting the acceptance or rejection of the product; and
3. Defined method for the disposition of rejected or nonconforming products.
c. Your firm did not establish written procedures for the incoming verification of the metal alloy specifications from the original manufacturer.
4. Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
a. Your firm's unsigned procedure for controlling design change, "Product Design Procedure," only states that "Gresco Products does not make changes in the design of any products." The procedure does not include a description of how your firm ensures that design changes are identified, documented, validated or verified, reviewed, and approved before they are implemented.
b. Your firm made a change in the Directions for Chair Side and Lab Use labeling for the Oral Ceram-Etch Gel device on or about December, 2010. However, your firm did not document the reason or justification for the change.
c. Your firm changed the syringe used to package the Met-Etch, Ceram-Etch, and Enam-Etch devices from a 2 mL (b)(4) syringe to a 3 mL (b)(4) Syringe. However, this change was not documented as a design change.
5. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
a. Your firm's unsigned and undated procedure, "Supplier Evaluation," lacks the following:
1. Requirements, including quality requirements, to evaluate suppliers, contractors, or consultants;
2. Definition of the type and extent of control to be exercised over the product, service, suppliers, contractors, and consultants, based on evaluation results;
3. Maintenance of records of acceptable suppliers, contractors, and consultants; and
4. Establishment and maintenance of purchasing data that describe or reference the specified requirements for purchased or received product and services.
b. Your firm's unsigned and undated procedure, "Supplier Evaluation," states that the company history, product sample, and price quotes should be requested and that tests on performance and stability should be evaluated. However, your firm did not maintain documentation to show that supplier evaluations were performed in accordance to the procedure.
c. Your firm's undated DMR for Ceram-Etch device, "Device Master Record Index for Ceram-Etch," states in its purchase specification section that "Hydrofluoric acid, (b)(4)" should be used for the manufacture of Ceram-Etch device. However, your firm purchased on June 30, 2010, (invoice #22782) a different concentration of Hydrofluoric Acid (b)(4) without a proper evaluation and did not document the change of concentration.
d. Your firm did not have a purchase specification for the incoming casting alloy.
6. 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). For example, your firm's undated procedure, "Complaint Handling Procedure," lacks the following:
a. Ensure that complaints are received, reviewed and evaluated by a formally designated individual.
b. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting (MDR).
7. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm did not establish quality audit procedures nor provide documentation showing that quality audits were ever conducted.
8. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of part 820 and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented, as required by 21 CFR 820.20(c). For example, your firm does not have procedures for management review and management has not reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency.
9. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. For example, your firm did not have written document control procedures to define how changes to documents are initiated, reviewed, documented, approved, and signed by responsible individuals, and how records of changes are maintained. Specifically, your firm's device master records, manufacturing procedures, and complaint handling procedures reviewed during the inspection have no approval signature, effective date, and revision number.
10. Failure to maintain a device master record (DMR) for each type of device to include or refer to the location of device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, as required by 21 CFR 820.181.
a. Your firm's DMRs for the Ceram-Etch, Met-Etch Gel, Cari-D-Tect, and Enam-Etch devices did not include the procedures and requirements for expiration dating.
b. Your firm did not maintain a DMR for Etch-Guard and for the cirrus alloy.
c. Your firm's undated DMR for Ceram-Etch did not include the quality control procedures and specifications for releasing the etching kits and all items contained in the kit.
11. Failure to establish and maintain adequate procedures to ensure that the device history records for each batch, lot, or units are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184. For example, your firm did not maintain the completed batch record form used to record the quantities of ingredients/raw materials weighed, verified, and added during the lot production of Enam-Etch, lot #8K454, dated December 12, 2008.
12. Failure to maintain distribution records that include or refer to the location of the name and address of the initial consignee, the identification and quantity of devices shipped, the date shipped, and any control number used, as required by 21 CFR 820.160(b). For example, your firm stated that it does not have distribution records, only invoices. However, your firm does not record the lot number or other control number on its invoices. Specifically, your firm's invoices # 98318, dated December 16, 2009, and # 102633, dated May 2, 2011, lack lot numbers or control numbers.
Our inspection also revealed that the Etch-Guard Protective Gel is adulterated under section 501 (f)(1)(8) of the Act, 21 U.S.C. § 351 (f)(1)(8), because your firm does 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 under section 502(0) the Act, 21 U.S.C. § 352(0), because you did not notify the Agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before agency. [21 C.F.R. § 807.81 (b)]. The kind of information your firm needs to submit in order to obtain approval or clearance for the device is described on the internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decides whether the product may be legally marketed.
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 you have taken to correct the noted violations, as well as an explanation of how you plan 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 you have taken. If your 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 response should be comprehensive and address all violations included in this Warning Letter.
Your firm's response should be sent to Mr. Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact Mr. Ta at 214-253-5217.
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 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. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Reynaldo R. Rodriguez, Jr