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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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SCI International, Inc. 07-Apr-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Baltimore District Office
6000 Metro Drive
Suite 101
Baltimore, MD 21215-3215
Telephone: (410) 779-5454


FEI: 3003791481

April 7, 2005


WARNING LETTER
05200219

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Mahmoud M. Sales, President
SCI International, Inc.
12362 Parklawn Drive
Rockville, MD 20852-1827

Dear Mr. Sales:

During an inspection of your establishment located in Rockville, Maryland, from January 26 through February 4, 2005, our investigators determined that your establishment manufactures human chorionic gonadotropin (HCG) test systems. Human chorionic gonadotxopin (HCG) test systems are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(h)).

The above-stated 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 manufacturing, packing, storage, or installation are hot in conformance with the Quality System Regulation for medical devices, as specified in Title 21, Code of Federal Relations (CFR), Part 820, as follows:

1. Failure of management with executive responsibility to ensure that an adequate and effective quality system, as defined in 21 CFR 820.3(v), has been fully implemented and maintained at all levels of the organization, as required by 21 CFR 820.20. For example:

a. Quality system procedures have not been established, as required by 21 CFR 820.20(e).

b. Procedures for identifying training needs and ensuring all personnel are adequately trained have not been established, as required by 21 CFR 820.25

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198.

3. Failure to establish and maintain procedures for implementing corrective and preventive actions (CAPA) and to document all activities, as required by 21 CFR 820.100.

4. Failure to maintain device history records to demonstrate that the devices are manufactured in accordance with the device master record, as required by 21 CFR 820.184, for the following products:

a. New Choice - One Step urine HCG, cassette format, pregnancy test kits
b. Baby Test - One Step urine HCG, cassette format, pregnancy test kits
c. Family Dollar One Step - urine HCG, midstream format, pregnancy test kits

5. Failure to establish procedures for acceptance activities, including the acceptance of incoming product, the acceptance of in-process product, and the acceptance of finished devices, and to document such acceptance activities, as required by 21 CFR 820.80.

6. Failure to establish procedures to control labeling activities and failure to document the label used for each lot in the Device History Record as required by 21 CFR 820.120 and 21 CFR 820.120(d).

7. Failure to examine the labeling of devices for the correct expiration date and control number and to document the examination in the Device History Record as required by 21 CFR 820.120(b).

8. Failure to maintain device master records as required by 21 CFR 820.181 for the following devices:

a. New Choice - One Step urine HCG, cassette format, pregnancy test kits
b. Baby Test -One Step urine HCG, cassette format, pregnancy test kits
c. Family Dollar One Step - urine HCG, midstream format, pregnancy test kits.

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 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 the FDA. You also must promptly initiate permanent corrective and preventive action on your Quality System.

We remind you that not only must medical devices be manufactured in accordance to the Quality System Regulations, but because they are in vitro diagnostic devices, they must also comply with the requirements in 21 CFR Part 809.

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.

You should 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.

We acknowledge receipt of your response dated February 17, 2005 to the FDA-483 issued to your Firm on February 4, 2005. Based on our review of the corrective actions outlined in the response, the corrective actions are not adequate to correct the violations of the Quality System Regulation cited above and on the FDA-483. The response appears general in nature and does not address the operations at your establishment. For example, procedures [redacted] and [redacted] are included with your response, these procedures do not outline the specific test methods or the standards the devices will be tested against. The response also includes an executed Device History Record (DHR), which includes a copy of the labeling used to label lot [redacted]. The labeling does not appear to state the expiration date of the device, as required by 21 CFR 809.10(a)(6)(i). In addition, the DHR does not include any acceptance records that demonstrate the device was manufactured in accordance to the Device Master Record. Additional guidance on the Quality System Regulations is available on FDA's website at www.fda.gov.

Please notify this office in writing within 15 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 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215, Attention: Steven B. Barber, Compliance Officer. Mr. Barber can be reached at (410) 779-5134.

Sincerely yours,

/S/

Kirk Sooter
Acting District Director
Baltimore District