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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Alpha Omega Manufacturing, Inc. 25-Aug-05

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

Public Health Service
Food and Drug Administration


2098 Gaither Road
Rockville MD 20850

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_ ~ DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration
Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145
August 25, 2005
Ref: 2005-DAL-WL-25
Mr. Luther M. King, President
Alpha Omega Manufacturing, Inc.
110 Main Street
Grapeland, Texas 75844
Dear Mr. King:
During an inspection of your establishment located in Grapeland, Texas, an July 12
through 28, 2005, our investigator determined that your firm is a specification
developer for the Dual2 Cooler-Heater, a cardiopulmonary bypass temperature
controller used to control the temperature of the water entering and leaving a heat
exchanger which is used by clinical cardiovascular perfusionists during surgery .
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, your firm was issued a List of Inspectional
Observations, Form FDA-483 (copy enclosed), which identified a number of
significant QS Regulation violations including, but not limited to, those described
Page 2 - Mr. Luther M. King, President
Alpha Omega Manufacturing, Inc.
August 25, 2005
1 . Failure to establish and maintain procedures for acceptance or rejection of
finished devices, including documentation of the results of acceptance or
rejection, as required by 21 CFR 820.80(d) and (e) [FDA-483 Item 6] . For
a) Your firm did not document the results of your firm's own verification
testing to confirm . the acceptance results provided by the contract
b) Your firm stated that the contract manufacturer was supposed to test the
device's over-tempetature alarm at or above= C to verify the device's
automatic shutdown and audible alarm. However, of the 13 contract
manufacturer's inspection forms reviewed, none documented the results
of this fail-safe feature.
2. Failure to establish and maintain procedures for rework, including retesting
and re-evaluation of the nonconforming product after rework, to ensure that
the product meets its current approved specifications, as required by 21 CFR
820.90(b)(2) [FDA-483 Item 8) . For example, the contract manufacturer
delivered three devices that . were found to malfunction during your firm's
finished device testing . You verbally stated that your firm repaired and
retested the devices for .acceptance but did not document that the devices
were reworked_ Furthermore, your firm notified the contract manufacturer of
the device problems - but did,- not document the results of your firm's
notification .
3. 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] . For example:
a) Your firm has not established procedures defining the specific types of
information (e .g. dates of manufacturing, quantity manufactured and
released for distribution, and device labels and labeling) and acceptance
records needed to be included in the device history records.
b) Of the 13 customer folders (device history records) reviewed for the
devices manufactured in 2005, your firm failed to keep its own inspection
Page 3 - Mr. Luther M. King, President
Alpha Omega Manufacturing, inc.
August 25, 2005
4. Failure to establish and maintain procedures to ensure that all purchased or
otherwise received product and services conform to specified requirements,
including evaluation of suppliers, contractors, and consultants, as required by
21 CFR 820.50(a) [FDA-483 Item 5]. For example, in one instance your firm
visited the contract manufacturer to discuss a manufacturing error causing
three devices to malfunction. And in other instances your firm visited the
contract manufacturer to discuss details of device performance specifications
and their ability to meet your firm's device quality requirements and
specifications . The results of your firm's evaluation of the contract
manufacturer's ability to meet your firm's quality requirements and
specifications were not documented .
5. Failure to establish and maintain procedures to control the design of the
device in order to ensure that specified design requirements are met, as
required by 21 CFR 820.30 [FDA-483 Items 2 and 7]. For example:
a) Your firm failed to adequately establish design control procedures and
maintain records for the design input requirements, design outputs, design
verification or validation, design review, and design transfer for your firm's
device design when it designed and manufactured the devices in-house
from February 9, 2001 through the end of 2003. See 21 CFR 820.30(a)-
b) In 2004, your firm outsourced its in-house manufacturing of the devices to
the contract manufacturer. This was considered a design change
affecting the design transfer of the original device design specifications .
Your firm failed to establish design transfer procedures to describe and
ensure (a) how device design specifications are transmitted to the contract
manufacturer, (b) how device design specifications are correctly translated
into manufacturing processes at the contract manufacturer, and (c) how
your firm verifies that the contract manufactured devices meet your firm's
device design specifications. See 21 CFR 820.30(h)-(i) .
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
Page 4 - Mr. Luther M. King, President
Alpha Omega Manufacturing, Inc.
August 25, 2005
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, andlor 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 Mr. Ta at 214-253-5217.
Michael A. Ch
Dallas District Director
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