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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alerchek, Inc. 31-May-07

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




May 31, 2007

Ms. Emily Baker, Owner
Alerchek, Inc.
203 Anderson Street
Portland, Maine 04101 -2458

Dear Ms. Baker:

During an inspection of your firm located in Portland, Maine on May 7 through May 8, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Total Human IgE Quantitative Microwell ELISA Assay. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

The 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, the manufacture, packing, storage or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations, (C.F.R.), Part 820. These violations include, but are not limited to, the following:

1. Failure to establish an adequate and effective quality system that has been fully implemented and maintained at all levels of the organization, as required by 21 C.F.R. 820.20(a).

During the FDA inspection, we observed significant violations as they relate to a number of quality system requirements, including lack of a quality policy that is understood, implemented and maintained; lack of appointment of a management representative to oversee and maintain quality system; lack of management reviews of the quality system; and lack of a total quality plan which defines the quality practices.

In your response to this Warning Letter, please address how your management will be addressing these violations. We need to be assured that an effective quality system will be implemented immediately.

2. Failure to establish procedures for quality audits, as required by 21 C.F.R. 820.22.

For example, your firm does not have any quality audit procedures in place to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. To date no audits have taken place.

3. Failure to establish and maintain procedures for implementing corrective and preventative action (CAPA) and to document all CAPA activities and their results, as required by 21 C.F.R. 820.100(a) and (b).

For example, your firm does not have any CAPA procedures and does not utilize CAPA actions in response to observations.

4. Failure to evaluate complaints to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting, as required by 21 C.F.R. 820.198(a)(3).

For example, your firm does not maintain a complaint log nor do you have a written MDR procedure to ensure reporting of any complaint representing an event this is required to be reported to FDA.

5. Failure to assure that a process whose results can not be fully verified by subsequent inspection and test, has been adequately validated and approved according to established procedures, as required by 21 C.F.R. 820.75(a).

For example, the [redacted] used to sterilize conjugates for the Total Human IgE and the Human Specific IgE assay as not been validated or verified. Sterile filling of IVD components after sterilization in an [redacted] as not been validated.

6. Failure to establish and maintain procedures to control all documents, as required by 21 C.F.R. 820.40.

For example, your firm has not established, documented, or implemented any document control procedures.

7. Failure to establish and maintain procedures for receiving, in-process, and finished device acceptance activities, as required by 21 C.F.R. 820.80(a).

For example, your firm has not established, documented, or implemented acceptance activities. Specifically, production batch records and kit assembly records consistently failed to have approval signatures. Production batch records had missing information, and did not reflect acceptable recordkeeping practices for corrections (i.e., crossing out material with a single line and initialing the change).

8. Failure to document the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date, as required by 21 C.F.R. 820.72(b)(2).

For example, there is no evidence of any equipment calibration. Specifically, the [redacted] System used for filling the plates has not been calibrated per manufacturer's recommendations since March 2001.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 money penalties. Also, 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, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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 response should be sent to: Maria P. Chaput, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Ms. Chaput at 781 596-7732.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,


Gail T. Costello, District Director
New England District

Attachment: FDA-483 dated May 8, 2007