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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Roth International Ltd. 15-Oct-01


Food and Drug Administration
Chicago District
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
Telephone: 312-353-5863

October 15, 2001

Mr. Richard J. Bryan, President and Owner
Roth International Ltd.
669 West Ohio Street
Chicago, IL 60610

Dear Mr. Bryan:

During an inspection of your firm from May 22 to May 25, 2001, Investigator Alicia Mozzachio determined that your establishment manufactures dental cement powders, EDTA solutions, and Myrrh & Benzoin Tincture. Dental cement powders and EDTA solutions manufactured at your facility are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). Myrrh & Benzoin Tincture manufactured at your facility are drugs as defined by Section 201(g) of the Act.

The inspection revealed that the devices manufactured at your facility are adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packing, storage, or installation are not in conformance with the Quality System regulation for medical devices, as specified in Title 21, Code of Federal Regulations (21 CFR), Part 820, as follows:

1. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. For example. there is no test data to assure that the REDTA Aqueous Irrigant contains 17% of Disodium Ethylenedinitrilotetraacetate (EDTA) as indicated on the label.

2. Failure to maintain the Device History Record (DHR). For example, the DHR lacked raw data sheets used during manufacturing/repackaging operations.

3. Failure to establish and maintain procedures to ensure that contamination, or other adverse effects, to product does not occur during handling. For example:

3.1. Your firm lacked cleaning validation studies to assure that residual [redacted] used to clean product areas on manufacturing equipment, is not carried over into subsequent batches of product. [redacted] was used to clean the mill and V-blender used in the production of Root Canal Cement and the dosing equipment used for repackaging Eugenol USP.

3.2. Your firm lacked written cleaning procedures for the equipment used in the manufacture/repackaging operations and cleaning was not documented.

4. Failure to establish and maintain adequate procedures to control labeling activities. For example, inspection and approval of incoming labels/labeling for accuracy was not documented. There were no approved master labels for comparison purposes. Also, there was no reconciliation of labels/labeling.

5. Failure to document calibration activities. For example, there was no documentation of the daily, or as used, calibration of the pH meter used to test the pH of REDTA Aqueous Irrigant. Also, there were no certified buffers on site during the inspection.

The inspection covering production of drug products revealed significant deviations from Current Good Manufacturing Practice Regulations (CGMP), 21 CFR Part 211. These CGMP deviations cause these drug products to be adulterated within the meaning of Section 501 (a)(2)(B) of the Act. These deviations include the following:

1. Failure to perform stability testing to support that Myrrh & Benzoin Tincture remains within specifications before its expiration date.

2. Failure to retain reserve representative samples of each lot of Myrrh & Benzoin Tincture produced.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483, Inspectional Observations, issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment?s quality system. You are responsible for investigating and determining the causes of the violations identified by FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.

You may obtain more information about the Quality System Regulation for medical devices by contacting FDA?s Division of Small Manufacturer?s Assistance at 800-638-2041, or the Device Advice web site (http://www.fda.gov/cdrh/devadvice/).

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, no premarket submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.

We request that you take prompt action to correct these deviations. Failure to promptly correct these deviations 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 penalties.

Please notify this office in writing within 30 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. If corrective action cannot be completed within 30 working days, state the reason for the delay and the time within which the corrections will be completed.

We acknowledge the receipt of your responses, dated June 3 and August 6, 2001, concerning the investigators? observations noted on the Form FDA 483. We have reviewed your responses and found they are inadequate because your response to Observation 4 does not address documentation of equipment cleaning. The second sentence of Observation 4 addresses this deficiency.

Your response should be sent to Michael Lang, Compliance Officer, at the above address.

Raymond V. Mlecko
District Director