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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Bon Secours Health System Incorporated 10-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Baltimore District Office

Central Region

6000 Metro Drive, Suite 101

Baltimore, MD 21215-3215

Telephone: (410) 779-5454

FAX: (410) 779-5707

FEI: 3003229535

02-BLT-06

December 10, 2001

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Christopher M. Camey, CEO

Bon Secours Health System Incorporated

1505 Marriottsville Road

Marriottsville,MD21104

Dear Mr. Carney,

The Food and Drug Administration inspected your medical gas facility located at 8143 Staples Mill Road, Richmond, Virginia, on November 13, 14, and 16, 2001. Medical gases are drug products as defined by Section 201 (g) of the Federal Food, Drug, and Cosmetic Act (the Act). Our inspection found significant deviations from Current Good Manufacturing Practice (CGMP) Regulations for medical gases, Title 21, Code of Federal Regulations (21 CFR), Part 211. Such deviations cause your medical gases to be adulterated within the meaning of Section 501(a) (2) (B) of the Act, in that the

methods used in or the facilities or controls used for their manufacturing, processing, packing, storage, or holding are not in conformance with GMP regulations.

The deviations include the following:

  1. Failure to test each batch of drug product for identity and strength of each active ingredient prior to release (21 CFR 211.165) in that:

a. There is no documentation to show that your firm tested incoming lot [redacted] and

lot [redacted] of liquid medical oxygen for identity and strength. Also, no certificates of analysis (COA) were available for these lots. There is no documentation to show that firm employees witnessed the testing of these lots at the supplier.

 

b. There is no documentation to show that your firm tested the following incoming lots

identity: lot [redacted] and [redacted]. Also, your firm does not have documentation to show that your employees witnessed the testing of these lots at the supplier.

2. Failure to establish written procedures designed to assure that drug products have the

identity, strength, quality and purity they purport or are represented to possess, in that:

a. Your firm has failed to establish written procedures for the testing and release of

incoming liquid oxygen (21 CFR 211.80);

b. Your firm has failed to establish written procedures for the receipt, filling, and

delivery of liquid medical oxygen (21 CFR 211.100);

c. Your firm has failed to establish written procedures to assure that the correct oxygen

label is used on liquid oxygen home units filled by the firm. In addition, there is no

documentation for the receipt and examination of oxygen labels (21 CFR 211.130);

d. Your firm has failed to establish written procedures for the receipt, identification,

storage, handling, sampling and examination of all oxygen labels. In addition, there

are no procedures for reconciliation, issuance, return, and security of oxygen labels

(21 CFR 211.122); and

e. Your firm has failed to establish written procedures for the storage and distribution of

filled compressed medical oxygen (21 CFR 211.150).

3. Failure to establish and document the responsibilities of the quality control unit

(21 CFR 211.22). For example;

a. There are no written procedures detailing how and when various quality control

functions will be performed.

b. Your firm?s quality control unit failed to review all entries in the liquid oxygen filling

records for accuracy and completeness.

The above is not intended to be an all-inclusive list of violations. It is your responsibility to ensure adherence to all requirements of the Act and regulations at your facility. The specific violations noted in this letter and on the Form FDA-483 issued at the closeout of the inspection, maybe symptomatic of serious underlying problems in your firm?s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to promptly correct these violations may result in regulatory sanctions without further notice. These sanctions include, but are not limited to, seizure and/or injunction.

Federal agencies are advised of the issuance of all Warning Letters concerning drug products so that they may take this information into account when awarding contracts. By copy of this letter, we are advising the Health Care Finance Administration (HCFA) that our inspection revealed significant deviations from the Act. They may elect to defer or discontinue payment for any health care product in violation of state or federal law.

Please notify this office in a detailed written response within 15 working days of receipt of this letter, of the steps you have taken to correct the noted violations and to prevent recurrence. If corrective action can not be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

You should direct your response and questions to the Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215-3215, to the attention of Vinetta Howard-King, Compliance Officer. Ms. Howard-King can be contacted at telephone number (410) 779-5454 x 413.

Sincerely,

Lee Bowers

Director, Baltimore District