Inspections, Compliance, Enforcement, and Criminal Investigations
G&S Instrument Company 22-Nov-05
Department of Health and Human Services
Public Health Service
November 22, 2005
RETURNED RECEIPT REQUESTED
Mr. William M . Grace, President and Owner
G&S Instrument Company
6851 Montgomery Road
Midlothian, Texas 76065-4829
Dear Mr. Grace:
During an inspection of your establishment located at the above-referenced address on October 19, 24, 2005 and November 2, 2005, our investigator determined that your firm manufactures the Seager Model 14 Electroejaculator System (one Model 14 power unit and two rectal probes) that is indicated for use in neurologically impaired males over the age of 18 years and who are anejaculatory due to spinal cord injury, retroperitoneal lymph node dissection, idiopathic, diabetes, spinal bifida, pelvic surgery complications, multiple sclerosis, and neurological impairments. This product is a device 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 your devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)) because the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) Regulation for medical devices, as specified in Title 21, Code of Federal Regulations (CFR), Part 820.
At the close of the inspection, you were issued a List of Inspectional Observations, Form FDA-483, which identified a number of significant QS Regulation violations including, but not limited to, those described below.
Quality System Regulation
1. Failure to establish and maintain procedures for the identification, documentation, validation or verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i) [FDA-483 Item 1], a repeat observation from the previous inspection conducted by the Texas Department of State Health Services (DSHS) in November 2002. For example:
a) Your firm failed to establish a written design change procedure to explain how design changes are to be initiated, reviewed, verified or validated, documented, and approved.
b) During the current inspection, you verbally stated that the original device design specified a maximum AC voltage output of [redacted] and that after independent consultation, your firm reduced the maximum AC voltage output to [redacted] in September 2002. Our review of your specification developer's [redacted] indicated that the maximum AC voltage output is [redacted]. Your firm did not document who (your firm or the specification developer) initiated and approved this design change and the reason for the design change.
c) Your firm failed to provide documentation explaining whether your firm or the specification developer has conducted and documented any risk analysis of the design change or the rationale for not conducting a design risk analysis. There is no documentation documenting all possible risks that can adversely affect the patient and the controls that can be implemented to reduce the probability and severity of risks.
d) Your firm failed to provide design verification or validation documentation proving whether the change in device's maximum voltage output still met the user needs and intended uses.
2. Failure to establish and implement adequate procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d), and to document acceptance records, as required by 21 CFR 820.80(e) [FDA-483 Items 2, 5, and 6], a repeat observation from the previous DSHS inspection of November 2002. For example:
a) Your firm manufactures the rectal probe as a stand-alone device accessory but failed to establish a written testing procedure, or to conduct and document finished product testing for each rectal probe. You verbally stated that you hold the rectal probe by hand to feel if it is properly heated or overheated . All probe testing was verbal in nature and was not documented.
b) The "Pass/Fail" portion of the power unit testing was filled out before the power unit testing was actually conducted.
c) The test results were not documented in sufficient details to demonstrate how the power unit passed its finished product testing. The test results were simply recorded as either "Pass" or "Fail". For example, your firm failed to explain and document quantitative test results and specific acceptance criteria for the power unit's test parameters, such as the electrode temperature, safety alarm functions, current and voltage output, elapsed timer, and stimulation counter.
3. Failure to establish and maintain procedures for acceptance or rejection of incoming product, including documentation of the results of acceptance or rejection, as required by 21 CFR 820.80(b) [FDA-483 Item 2], a repeat observation from the previous Texas DSHS inspection of November 2002. For example, your firm does not have written procedures and maintain acceptance records for the inspection or verification of incoming products, such as analog voltmeters, variable transformers, thermistor meters, resistors, and other semi-conductors.
4. Failure to maintain device master records (DMR's) to include "or refer to the location of device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181 [FDA-483 Items 4 and 51, a repeat observation from the previous Texas DSHS inspection of November 2002. For example:
a) Your firm failed to establish complete and adequate written assembly and testing procedures for the power unit and the rectal probe. Additionally, you verbally stated that after the milling and buffing process, each rectal probe is cleaned to remove manufacturing debris. However, there is no written cleaning procedure and record.
b) The two drawings for the body of the 1-1/4 and 1-/8 rectal probe do not show the locations of the patient electrode contact and thermistor.
c) The two drawings for the body of the 1-1/4 and 1-/8 rectal probe contain handwritten changes to the milling and buffing process without a description of the changes, dates and approval of the changes.
d) The schematic/wiring diagram used to assemble the power unit do not document component specifications, unit specifications for handwritten values, diagram version number, and dates of approval and effective.
e) Your firm failed to maintain an approved master and current copy of the device labels or labeling for the power unit and the rectal probe.
5. Failure to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184 [FDA-483 Item 4 and 5]. For example:
a) Your firm does not maintain or reference a production copy of the device labels or labeling for the power unit and rectal probe manufactured on a particular production date in the device history record.
b) Your firm's device history records do not document acceptance testing results for each rectal probe.
c) Your firm's device history records do not document complete and adequate acceptance testing results for each power unit.
6. Failure to establish and maintain instructions and procedures, including documentation of servicing, for performing and verifying that servicing meets the specified requirements, as required by 21 CFR 820.200(a) and (d) [FDA-483 Item 7]. For example, your firm's device service records do not always document the device serial number, the types of repairs and tests that were performed on the devices during servicing, and the results of each repair and test.
7. Failure to establish and maintain data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received product and services that must be met by the suppliers, contractors, and consultants, as required by 21 CFR 820.50(a) and (b) [FDA-483 Item 3], a repeat observation from the previous Texas DSHS inspection of November 2002. For example, your firm has not established and documented specific quality requirements and specifications, including the names and addresses of the approved vendors, for incoming components (e.g., cables and plastic material used to manufacture the rectal probe, and other electronic components used to manufacture the power unit).
8. 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 [FDA-483 Items 8 and 9], a repeat observation from the previous Texas DSHS inspection of November 2002. For example, your firm has never conducted any internal audits of its quality system and has no written audit procedures defining (a) how and what specific areas of your firm's quality system are to be audited, and (b) the audit interval. The lack of conducting an internal audit is evident in the repeat observations cited during the current FDA and the previous Texas DSHS inspection.
9. Failure to establish and maintain procedures for implementing corrective and preventive actions and to ensure that all the requirements of 21 CFR 820.100(a)(1) through (a)(6) and 820.100(b) are met [FDA-483 Item 11], a repeat observation from the previous Texas DSHS inspection of November 2002.
Responding to This Letter
Due to the serious and repeat nature of the inspectional observations cited by the FDA and Texas DSHS, we suggest your firm use a qualified quality system consultant to help identify any gaps in your firm's quality system in order to establish and implement complete and comprehensive quality system procedures that will (a) correct the inspectional observations issued at the conclusion of the inspections on November 2002 and 2005, and the items identified in this warning letter, and (b) prevent a recurrence of CGMP violations.
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 the regulations. The specific violations noted in this letter and in the Form FDA-483 may be symptomatic of other serious underlying problems in your firm's manufacturing and quality assurance systems.
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 applications for premarket approval to which the Quality System regulation deficiencies are reasonably related will be 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 violations. 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/or civil penalties.
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken, or will take to identify and correct the noted violations, including (1) the timeframes within which the corrections will be completed, (2) any documentation indicating the corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to ensure that similar violations will not recur.
Your response should be sent to Thao Ta, Compliance Officer, DAL-DO, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, TX 75240. If you have any questions about the contents of this letter, please contact Thao Ta at 214-253-5217.
David Glasgow for for Michael A. Chappell
District Director Dallas