[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28065]


[[Page Unknown]]

[Federal Register: November 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93N-0205]

 

Daco Laboratories, Ltd.; Withdrawal of a Notice of Opportunity 
for Hearing Proposing To Withdraw Approval of Medicated Feed 
Applications

AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.

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SUMMARY: The Center for Veterinary Medicine (CVM), Food and Drug 
Administration (FDA), is withdrawing a notice of opportunity for 
hearing proposing to withdraw approval of seven applications held by 
Daco Laboratories, Ltd., for animal feeds bearing or containing new 
animal drugs (NAD's). CVM has determined that the firm is in compliance 
with current good manufacturing practice regulations for medicated 
animal feeds and has instituted a system to maintain its compliance 
status.

EFFECTIVE DATE: November 15, 1994.

FOR FURTHER INFORMATION CONTACT: Karen A. Kandra, Center for Veterinary 
Medicine (HFV-246), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1765.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of August 17, 1993 (58 FR 43638), CVM provided an opportunity 
for hearing on a proposal to withdraw approval of seven medicated feed 
applications (MFA's) held by Daco Laboratories, Ltd., for the 
manufacture of animal feeds bearing or containing new animal drugs. CVM 
took this action based on the failure of the firm to achieve sustained 
compliance with agency current good manufacturing practice (CGMP) 
requirements for medicated animal feeds after a series of inspections 
that began on August 17, 1988, and concluded on October 5, 1992.
    In response to the notice, Daco Laboratories requested a hearing 
and stated that it had corrected the CGMP deviations and was currently 
in compliance. Additionally, the firm requested that FDA reinspect its 
facility to verify its compliance status.
    On July 15, 1994, FDA reinspected Daco Laboratories and found that 
the firm had corrected all previous CGMP deficiencies and was in 
compliance at that time. In contrast to past inspections, however, the 
firm had instituted a system that should sustain its state of 
compliance. Accordingly, CVM is withdrawing the August 17, 1993, notice 
of opportunity for hearing proposing to withdraw approval of seven of 
the firm's MFA's.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (sec. 512 (21 U.S.C. 360b)) and under authority delegated to the 
Director, Center for Veterinary Medicine (21 CFR 5.84).

    Dated: November 2, 1994.
Richard H. Teske,
Deputy Director, Pre-market Review, Center for Veterinary Medicine.
[FR Doc. 94-28065 Filed 11-14-94; 8:45 am]
BILLING CODE 4160-01-F