94-31251. Compressed Medical Gases; Current Good Manufacturing Practices; Notice of Workshop

[Federal Register Volume 59, Number 244 (Wednesday, December 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-31251]


[[Page Unknown]]

[Federal Register: December 21, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
 

Compressed Medical Gases; Current Good Manufacturing Practices; 
Notice of Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop for producers of medical gases. The workshop will present 
information to assist medical gas producers in complying with the 
current good manufacturing practice (CGMP) regulations governing their 
industry.

DATES: The public workshop will be held on January 18, 1994; 8 a.m. to 
4:30 p.m.

ADDRESSES: The public workshop will be held at the Volpe National 
Transportation Systems Center Auditorium, 55 Broadway Kendall Square, 
Cambridge, MA 02142.

FOR FURTHER INFORMATION CONTACT: George R. Walden, Small Business 
Representative, Food and Drug Administration, 850 Third Ave., Brooklyn, 
NY 11232, 718-965-5300 ext. 5528, FAX [phone]. Those persons 
interested in attending this workshop should call the contact person 
listed above or fax their registration, including firm name, address, 
name of contact, and telephone number to 781-965-5759. There is no 
registration fee for this workshop, but advance registration is 
recommended. Space is limited and all interested persons are encouraged 
to register early.

SUPPLEMENTARY INFORMATION: Recent inspections of medical gas 
transfillers and processors have demonstrated an alarming rate of 
noncompliance, resulting in the issuance of numerous warning letters, 
recalls, and in some cases, voluntary suspension of operations. FDA 
investigators have documented that many operators of these firms appear 
to lack the fundamental knowledge necessary to ensure full and 
continued compliance with the CGMP regulations. This workshop is being 
presented to inform persons associated with this FDA-regulated industry 
about the applicable CGMP and other agency requirements.

    Dated: December 14, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-31251 Filed 12-20-94; 8:45 am]
BILLING CODE 4160-01-F