Inspections, Compliance, Enforcement, and Criminal Investigations
Mastex Industries, LLC 17-Jun-04
Department of Health and Human Services
Public Health Service
June 17, 2004
RETURN RECEIPT REQUESTED
Frank Mast, CEO
Mastex Industries, LLC
2035 Factory Lane
Petersburg, VA 22803
Dear Mr. Mast:
During an inspection of your establishment located in Petersburg, VA, from April 5 - 8, 2004, our investigator determined that your firm manufactures heating pads. Heating pads are devices as defined by Section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that these devices 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 regulations for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
1. Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization. Specifically, management has not established and implemented a quality policy, management review procedures, quality planning procedures, and quality system procedures. [21 CFR 820.20]
2. The procedures for implementing corrective and preventive actions were not established, defined, and documented. Specifically, the firm has no written procedures in place to convey their corrective and preventive actions for Class II heating pads manufactured by the firm. [21 CFR 820.100]
3. Process control procedures that describe any process controls necessary to ensure conformance to specifications were not established, defined, and documented. Specifically, the firm does not have written production and process control procedures in place for Class II heating pads. Written production and process control procedures are required to address production and process changes, environmental control, personnel, contamination control, buildings, equipment, maintenance schedule, inspection, adjustment, and manufacturing material. [21 CFR 820.70]
4. Procedures to control the design process of the device were not established, defined, and documented. Specifically, the firm has no written design controls as required for Class II heating pads. Procedures to control the design process are required to address design input, design output, design review, design verification, design validation, and design transfer. 121 CFR 820.30]
5. Labeling procedures were not established, defined, and documented. Specifically, the firm has no written procedures in place to control labeling activities. Written procedures to control labeling activities are required to address label integrity, labeling inspection, labeling storage, and labeling operations. [21 CFR 820.120]
6. Document control procedures were not established, defined, and documented. Specifically, the firm has no written document control procedures in place to provide for document approval and distribution and document changes. [21 CFR 820.40]
This letter is not intended to be an all-inclusive list of deficiencies at your firm. 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-483 issued at 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 in your Quality System.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering award of contracts. 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 by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
We request that you notify this office in writing, within fifteen (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 can not be completed within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Your reply should be directed to Randy F. Pack, Compliance Officer, Food and Drug Administration, Baltimore District Office, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, please do not hesitate to contact Mr. Randy F. Pack at (410) 779-5454, extension 417.