Medico Medical Equipment & Supplies Inc 21-Feb-02

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Cincinnati District Office

Central Region

6751 Steger Drive

Cincinnati, OH 452373097

Telephone: (513) 679-2700

FAX: (513) 679-2771

February 21, 2002

WARNING LETTER

CERTIFIED MAIL

CIN-02-WL-12579

RETURN RECEIPT REQUESTED

Brian R. Browning, President

Medico Medical Equipment & Supplies, Inc.

72 North Rocky River Drive

Berea, Ohio 440 17

Dear Mr. Browning:

The U.S. Food and Drug Administration conducted an inspection of your medical oxygen

(compressed and liquid) transfilling operation at the above Berea, Ohio address, on

January 30-31 and February 5, 2002. This inspection documented significant deviations

horn the current Good Manufacturing Practice regulations for drugs. These deviations

cause your medical gases to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

Specific deviations observed include:

1) Failure to test bulk incoming liquid medical oxygen upon receipt, prior to use in

filling cryogenic Dewars.

2) Failure to establish appropriate written procedures and batch production records

describing and documenting prefill, fill and postfill checks for cryogenic Dewars

and cryogenic home units.

3) Failure to test new and/or repaired cryogenic vessels (Dewars and home units) for

identity before distribution.

4) Failure to establish a formal quality control unit.

5) Failure to provide and document medical gas GMP training for each individual

responsible for medical gas transfilling and distribution operations.

6) Failure to establish, maintain and make available for FDA review medical oxygen

batch records for 8 of 12 months in the year 2000.

7) Failure to establish and follow appropriate calibration procedures for your oxygen

test meter. There was no record of calibration for this meter from 6/15/01 to

10/14/01 during which time oxygen was transfilled. Calibration records do not

document the calibration set point and records do not document that the calibration

record was reviewed and approved for accuracy and completeness.

8) Failure to establish and follow appropriate equipment calibration procedures. There

are no written procedures describing the frequency with which pressure/vacuum

gauges and thermometers are to be calibrated. Calibration tags on pressure/vacuum

gauges indicate these gauges were last calibrated 10/98 and were due for re-calibration 10/99. Written procedures for scales used in transfilling state they are to be calibrated annually. Records indicate these scales were last calibrated in 6/99.

9) Failure to establish and follow adequate label control procedures in that there are no

procedures for documenting receipt of drug labels and reconciling their distribution

and use.

10) Failure to follow established expiration dating procedures. Written procedures state

that medical gases transfilled into high pressure cylinders are to be assigned an

expiration date of 5 years. Batch records show various expiration dates assigned to

lots ranging from 2-5 years.

11) Batch records for compressed Oxygen USP lack written documentation (signatures

and dates) showing the records were reviewed and approved for accuracy ,

completeness and suitability prior to release and shipment. Batch records do not

document the daily zero check to verify appropriate functioning of the vacuum

gauge.

The above described violations are not intended to be an all-inclusive list of deficiencies

at your facility. It is your responsibility to assure that you adhere to all current

regulations applicable to your operations. Until these violations are corrected, Federal

agencies will be informed that FDA recommends against award of contracts for affected

products.

You should take prompt action to correct these violations. Failure to achieve prompt

correction may result in regulatory action without further notice. These include seizure

and/or injunction.

Please advise us in writing within fifteen (15) working days of receipt of this letter of the

specific actions you are taking to correct these violations. Your response should explain

each step you have taken to correct the noted violations, including steps taken to prevent

recurrence of similar violations. Include any documentation showing these 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 reply should be sent to the U.S. Food and Drug Administration, 6751 Steger Drive,

Cincinnati, Ohio 45237-3097, to the attention of Charles S. Price, Compliance Officer.

Any questions regarding this letter may be directed to Mr. Price at telephone (5 13) 679-

2700 extension 165.

Sincerely,

Mary A. Womack for Henry L. Fielden

District Director

Cincinnati District