Eagle Diagnostics, Inc. 3/3/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128

March 3, 2011

Ref: 2011-DAL-WL-05

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Robert H. Collins, President
Eagle Diagnostics, Inc.
545 Jealouse Way
Cedar Hill, Texas 75104

Dear Mr. Collins:

During an inspection of your firm located at the above-referenced address on October 18 through November 1, 2010, investigators from the United States Food and Drug Administration (FDA or Agency) determined that your firm manufactures and repacks in vitro diagnostics reagents for export only. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a medical device because it is 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 any function of the body.

This 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, their 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) (CFR), Part 820.

At the conclusion of the inspection, the investigators issued to you the Form FDA-483 (List of Inspectional Observations) which identifies a number of significant violations including, but not limited to, those described below. As of March 2, 2011, we have not received your response to the inspectional observations.

Quality System Violations

1. Failure to establish and maintain procedures for quality audits and conduct such audits to ensure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. FDA 483 Item 6.
Specifically:

You have not performed (b)(4) internal quality audits since January 20, 2006, as required by your SOP ED-004 "Internal Audit Procedure," dated June 1, 2005.

2. Failure to establish and maintain device master records (DMRs) 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 C.F.R. § 820.40, as required by 21 C.F.R. § 820.181.FDA 483 Item 2. Specifically:

You do not have device master records (DMRs) for the in vitro diagnostic reagents your firm has been manufacturing and repacking since 2005. For example, between September 2008 and October 2010, your firm manufactured and distributed several lots of Albumin (BCG) Reagent Sets, Bilirubin Total/Direct Reagent Sets, and Creatinine Direct Reagent Sets, and repacked and distributed several lots of Glucose (Oxidase) Reagent Sets, Amylase Reagent Sets, Hemoglobin Reagent Sets, and Cholesterol Reagent Sets.

3. Failure to establish and maintain procedures to ensure that the device history records (DHR) for each batch, lot, or units are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 C.F.R. § 820.184. FDA 483 Item 3. Specifically:

You have not maintained device history records for the in vitro diagnostic reagent sets your firm manufactured and repacked between September 2008 and October 2010.

4. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. These activities shall be documented. 21 C.F.R. § 820.72(a). FDA 483 Item 7. Specifically:

You have not performed and documented (b)(4) calibrations of the (b)(4) and (b)(4) instruments used for QC testing of the in vitro reagents since January 3,2006, as required by your SOP ED-014 "Calibration of QC Equipment," dated December 11, 2002. Further, you have not performed (b)(4) calibrations of the (b)(4) scale used to weigh powder reagents during repacking since June 29, 2005, as required by your SOP ED-010 "Calibration of (b)(4) Scales," dated April 15, 1999.

5. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 C.F.R. § 820.50. FDA 483 Item 4.

You failed to maintain acceptance records (Incoming Raw Material/Quality Control Worksheet) that document your visual inspection of the product label and review of the certificate of analysis for each incoming reagent received at your firm, as required by your SOP ED-018 "Incoming Raw Material Receiving/Acceptance Record," dated January 1, 2004. When the investigators asked to review the COA for the Glucose (Oxidase) and the ingredients used in the manufacture of the Creatinine Direct Reagent Sets, you did not maintain the COA. Further, you have not documented your evaluation of the (b)(4) reagent suppliers since 2003.

This inspection also revealed that your firm is not registered with the FDA as a U.S. manufacturer of export only devices. You must appropriately register your establishment with the FDA. Failure to register as a U.S. manufacturer of export only devices is a violation of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the device was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360. Information on how to register can be found at http://www.fda.gov/cdrh/devadvice/3122.html.

Responding to This Warning Letter

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. 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, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved 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. You should 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 correction will be completed.

Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 North Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.

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 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,
 

/s/

Reynaldo R. Rodriguez, Jr.
Dallas District Director

 

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