JOHN D. COPANOS AND SONS, INC. V FDA
854 F.2d 510 (D.C. Cir. 1988)
NATURE OF THE CASE: This was a dispute over the sufficiency of notice on an agency’s
action.
FACTS: John D. Copanos & Sons, Inc., and Kanasco, Ltd., (Ds) manufacture and distribute
human and veterinary drugs, including, until recently, a number of sterile injectable
products. The injectable drugs were produced pursuant to a number of New Drug Applications
(NDAs) and New Animal Drug Applications (NADAs) approved by The FDA (P). P published a
Notice proposing to withdraw D's NDAs and NADAs for sterile injectable products because the
methods, facilities, and controls used to produce these drugs were inadequate to assure
their identity, strength, quality, and purity. D requested a hearing but it was denied by P
and P summarily withdrew its approval of the company's applications. P had conducted an
inspection of D's manufacturing facility, which revealed numerous deficiencies in
manufacturing and quality control procedures, including inaccurate and even falsified
manufacturing records, failure to calibrate laboratory equipment, unsanitary conditions in
the manufacturing area, and production of a subpotent and impure animal drug. P left with
the company a Form FDA-483 listing the deficiencies noted in the inspection. P sought to
enjoin D from the further manufacture and shipment of pharmaceuticals. Rather than
contesting the allegations in this complaint, D agreed that it would not manufacture or ship
any drugs without the prior written authorization of P, and the government dismissed the
complaint without prejudice. By letter D promised corrective measures in the future. Upon
request, P returned to verify a consultant's assessment of compliance. It failed again and
again a Form FDA-483 was left with all the problems listed. D again acknowledged the alleged
deficiencies, disputing some of the agency's conclusions but promising improvements in the
areas identified by the inspector. D also asked for approval to resume manufacturing (but
not shipping) veterinary drugs, on the ground that it was then in compliance. P refused and
D once again returned to evaluate results with respect to a media fill issue. D failed and P
once again left a Form FDA-483 listing the problems. In a follow up letter P stated that the
'underlying cause' of the company's problems was the number, training, and supervision of
personnel. D once again responded with a letter promising improvements in the company's
media fill process. P then learned that D had manufactured 23 lots--over one million
vials--of injectable veterinary drugs, in violation of the 1984 Agreement. Several thousand
vials had been shipped to customers without approval. In addition, the company withheld
records that would have revealed the shipments. P officials visited D to monitor the
company's media fills. D failed and P left yet another Form FDA-483. P filed a second
complaint for injunctive relief and returned to the company with a criminal search warrant.
P concluded that D had committed further violations of the CGMP record keeping requirements.
The district court by consent entered an interim order prohibiting D from making or
distributing injectable drugs without prior judicial authorization. D agreed to a 'Consent
Decree of Permanent Injunction.' A consultant recertified but once again an inspection by P
revealed violations. D disputed some of the agency's observations but again promised
improvements or changes in all the noted deficiencies. P again sought a court order to cease
the manufacture of all injectable drugs. D once again persuaded the agency, that the noted
deficiencies had been, or would be corrected. P authorized the company to resume
manufacturing and shipping injectable drugs, and so notified the court. When the FDA
reinspected D's manufacturing facility in September 1986, it noted numerous potential
violations. D's written response to Form FDA-483 disputed a number of the conclusions,
particularly the determination that facilities and equipment were invalidated. D nonetheless
promised a number of improvements. P again moved to enforce the 1985 Consent Decree. The
court eventually made the injunction permanent. P visited once again and encountered both
new and familiar problems. P published a notice proposing to withdraw D's NDAs and NADAs for
sterile injectable products. Notice required D, if it wanted a hearing, to submit 'the data,
information, and analyses relied on to justify a hearing, as specified in 21 C.F.R.
312.200,' and noted that the same regulation would govern any subsequent proceedings. D both
requested a hearing and moved for summary judgment. The motion for summary judgment was
based on the argument that the agency had not complied with the requirements in 21 U.S.C.
Secs. 355(e) and 360b(e)(2)(B) that it provide D with proper written notice 'specifying the
matter complained of' and 'a reasonable time after receipt of written notice' within which
to make adequate any deficiencies. P denied both the hearing request and the motion for
summary judgment, and ordered that D's NDAs and NADAs be withdrawn from the market. A
petition for reconsideration was also denied. D filed this petition for review.
ISSUE:
RULE OF LAW:
HOLDING AND DECISION:
LEGAL ANALYSIS:
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