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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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genX International Inc. 09-Aug-04

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

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781)596-7896


WARNING LETTER
NWE-33-04W

VIA FEDERAL EXPRESS

August 9, 2004

Michael D. Cecchi
President
genX International inc.
393 Soundview Road
Guilford, CT 06437

Dear Mr. Cecchi:

An inspection of your facility located at 393 Soundview Road,Guilford, CT was initiated by an investigational team from the Food and Drug Administration (FDA) On May 19, 24, and 27, 2004, and June 2, 2004. The inspection verified that your firm manufactures single lumen aspiration needles, air handling units, and embryo sustaining media. These products are medical devices, as defined in Section 201(h) or the Federal Food, Drug, and Cosmetic Act (the Act).

The inspection revealed that these devices are adulterated within the meaning of Section 509(h) of the Act, in that the methods used in or the facilities or controls used for manufacturing, packing, storing, or installation are not in conformity with the Quality System Regulation, Title 21, Code of Federal Regulations (CFR), Part 820, promulgated under Section 520(f)(1)of the Act. The following deviations were noted:

  • Failure to conduct and document process validation studies for the Single Lumen Aspiration Needle for the manufacturing processess of:

    o Sterilization (effectiveness of dose);
    o Packaging (integrity of heat-seeking process); and
    o Needle Wash (removing solvent residues associated with manufacturing).

  • Failure to maintain documented final acceptance procedures for single Lumen Aspiration Needles prior to release for distribution which include the failure to document:

    o All activities listed in the Device Master Record(DMR);
    o Review and signature of the designated official; and
    o The acceptance activities. the dates activities were performed, and the results.

  • Failure to maintain a complete documented and approved DMR for the Pioneer IVF Single Lumen Aspiration Needle which includes device and process specifications such as the failure to document:

    o Drawings, composition, and component specifications;
    o Equipment specifications, production methods, and procedures;
    o Acceptance criteria for components and finished products; and
    o Labeling specifications including methods and processes used.

  • Failure to maintain, complete, document, and review the Device History Records(DHR) for Single Lumen Aspiration Needles and the Global Embryo Sustaining Media products to demonstrate that the devices are manufactured in accordance with DMR including the failure to document:

    o The dates of manufacture;
    o The quantity manufactured;
    o The quantity released for distribution;
    o In-process and final acceptance records which demonstrate that the devices were manufactured in accordance with the DMR;
    o Labeling and identification/control number used for each device manufactured; and Sterility testing results

  • "Failure to have written procedures for the use and removal of manufacturing material during the manufacturing of Single Lumen Aspiration Needles to ensure that the material is removed or limited to en amount that does not adversely affect the devices' quality including:

    o Documentation that the firm has validated the quality of the air system used to dry the needles; and
    o Documentation that the firm has validated the effectiveness of the isopropanol water bath used to remove solvent residue/metals dust from incoming component needles.

  • Failure to conduct, control, and monitor production processes for the Single Lumen Aspiration Needles during assembly which include failure to:

    o Document the monitoring of the bioburden assay of the assembled device; and
    o Document environmental monitoring of the controlled access room prior to sterilization as required by the firm's sterility validation plan.

genX International inc. should take prompt action to correct the above deviations. Failure to correct deviations may result in regulatory actions being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies will be advised of the issuance of this warning letter so that may take this information into account when awarding government contracts.

We acknowledge receipt of your letter of response dated June 17, 2004, stating that you have contracted [redacted] as a full time consultant to advise and assemble the appropriate systems to maintain your Quality System as wall as assist with compliance audits and training of employees. The actions you propose for the Single Lumen Aspiration Needle appear adequate; however, you must also correct the remaining system-wide observations detailed during the inspection.

Please 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 prevent the recurrence of similar violations if corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.

You may direct your reply to Anthony P. Costello, Compliance Officer, at the address noted in the letterhead. If you have any questions concerning this matter, please contact Mr. Castello at (781) 598-7716.

Sincerely,

/S/

Gail Costello
District Director
New England District Office