Inspections, Compliance, Enforcement, and Criminal Investigations
Wyandotte Welding Supply 06-Nov-02
Department
of Health and Human Services Public
Health Service
Food and Drug Administration
Detroit District
1560 East Jefferson Avenue
Detroit, MI 432074179
Telephone: 313-226-6260
Warning Letter
2003-DT-03
CERTIFIED NIAIL
RETURN RECEIPT REQUESTED
November 6, 2002
Mr. John J. Cunningham
President .
Wyandotte Welding Supply, Inc.
Lab Gases Division
2025 Eureka Avenue
Wyandotte, MI 48192
Dear Mr. Cunningham:
An inspection of your medical oxygen manufacturing firm
was conducted on August 8-15, 2002 by Investigators Deanna Lampley and Jennifer
A. Kemp. At the conclusion of the inspection, a FORM FDA-483, List of
Inspectional Observations (copy attached) was issued to you.
The Oxygen USP sold by your firm is misbranded within
the meaning of Section 502(b)(2) of the federal Food, Drug, and Cosmetic Act
(the Act), and it is adulterated within the meaning of Section 501(a)(2)(8) of
the Act.
1. The compressed gas cylinders and the cryogenic
vessels of oxygen are misbranded in that they lack indication of the net
contents.
2. The cryogenic vessels of liquid oxygen are misbranded
in that the labels lack the established name of the product, ?Oxygen
Refrigerated Liquid LISP.?
Adulteration violations:
The Oxygen USP is adulterated based on the inspectional
evidence which revealed serious deviations from the Current Good Manufacturing
Practices for Finished Pharmaceuticals, Title 21, Code of Federal Regulations,
(C.F.R.) Part 211, as follows:
1. Your Quality Assurance Unit failed to perform their
functions and responsibilities as required in 21 C.F.R. 211.22. The failure is
demonstrated by the number and type of inspectional observations made during
this inspection.
2. You have failed to assure that each person engaged to
perform or to supervise the
3. Your quality control unit has failed to review all drug
product production and control records to determine compliance with established
written procedures before each batch is released or rejected, as required
by 21 C.F.R. 211.192. For example, see FDA-483 observation 3.
4. Your firm has failed to consistently document the performance
of an analysis of every
5. Your firm has failed to consistently document the calibration
of the [redacted] Oxygen analyzer instrument as required by 21 C.F.R. 211.160(b)(4).
For example, see FDA-483
6. Your firm has failed to maintain on file the
analytical method validation data for the [redacted]has ailed to maintain on
file the analytical method validation data for the [redacted] oxygen analyzer
instrument, as required by 21 C.F.R. 211.165(e). Although this deficiency was
not listed on the FDA-483, our Investigators reported that you presented no
additional information in support of validation of the instrument.
7. You have failed to consistently label your Oxygen USP
with a lot or batch number that
8. You have failed to assure that all labeling materials
not suitable for subsequent operations have been removed during the empty
cylinder preparation process, as required by 21 C.F.R. 211.130(e). For example,
FDA-483 observation 8 reported the failure to remove the obsolete lot
number/expiration date stickers prior to application of a fresh sticker for the
current batch.
9. The expiration dates observed on the recent filling
records appear to be set at four years from the fill date. This date is not
supported by appropriate stability testing as required by 21 C.F.R. 211.137.
FDA-483 observation 4 notes the expiration date is not 5 years from the fill
date, even though your USP LABEL SAMPLES instructions specify to use a five (5)
year date.
10. You have failed to follow the instructions in your
written procedure, USP LABEL SAMPLES, to include the cylinder volume on the
labeling as required by 21 C.F.R. 211.130(b). FDA-483 observation 4 notes that
cylinder volumes are not on the lot number stickers.
11. Your Quality Control Unit failed to approve (sign and
date) the three handwritten pages of notes titled, How to Fill Liquid Tanks
as required by 21 C.F.R. 211.100(a). See FDA-483 observation 9. These notes
were presented as representing the ?manufacturer?s
a. Do not provide for specific pre-fill inspection of the
cryogenic vessels as required by
b. Do not refer to any form or any other type of document
on which to record completion
12. You have failed to consistently maintain complete
batch production records that document performance of each required step in the
pre-fill, filling, testing, and labeling process as required by 21 C.F.R. 211 .188.
For example, see FDA-483 observations 10 and 11.
13. You have failed to document performance of the
annual calibration of the vacuum gauge as called for in your USP Equipment
Calibration procedure, as required by 21 C.F.R. 211.68(a). For example, see
FDA-483 observation 5.
14. The last calibration of the [redacted] performed on
February 18, 2000, failed to comply with your established written procedure, Calibration
Checklist Form 4 9-2 that also requires an annual calibration. This is a
violation of 21 C.F.R. 211.68(a). See FDA-483 observation 6.
The above is not intended to be an all-inclusive list of
deviations which may exist at your firm. It is your responsibility to ensure
that your firm is in full compliance with the Act and regulations promulgated
there under. Other Federal agencies are advised of the issuance of all Warning Letters
about drugs so that they may take this information into account when
considering the award of contracts.
We request that you take prompt action to correct these
deviations. Failure to make prompt corrections may result in regulatory action
without further notice, such as seizure and/or injunction.
Informational section
1. Although you failed to follow your written procedure
to include the contents of your containers on the small grocery-store sticker
labels along with the lot numbers, the FDA believes that you should indicate
the contents in the space provided on the formal cylinder shoulder labels. They
are a permanent label less likely to become separated from the container.
2. Your cylinder and cryogenic vessel labels must be revised
prior to February 19,2003 to bear the statement, ?Rx Only?. This must replace
the existing statement ?Caution: Federal Law Prohibits Dispensing Without
Prescription.? Enclosed are sample labels.
3. Concerning adulteration violation number nine (9)
above, the Food and Drug Administration currently recognizes the use of a five
(5) year expiration date as an industry practice, and is reviewing the data of
a petition from the [redacted] requesting exemption of medical gases from 21 C.F.R.
211.137 be used, but any other expiration dating period, whether supported by
your own stability studies.
Please notify this office in writing, within fifteen (15)
working days of your receipt of this letter, of the specific steps you have
taken to correct the noted deviations and to prevent their recurrence. If
corrective action cannot be completed within 15 working days, please state the reason
for the delay, and the time in which the corrections will be completed. Your
response should be directed to this office to the attention of Mr. Melvin 0.
Robinson, Compliance Officer (313) 226-6260, Extension 178.
Sincerely yours,
/s/
Joann M. Givens
District Director
Detroit District
