No determination made of the differential pressure existing
between sterile and non sterile areas.

Final filters not tested for integrity at the end of a sterile
filtration.

• Firm's own specifications not followed as no swabs were taken
from equipment used to process sterile drugs. Exposed agar plates
not incubated at room temperature to determine the presence of
molds.

Distilled water for injection will be stored for six days using
2/500 gallon tanks. The tanks have a combination vent/overflow
valves on top and are not equipped with bacteria removal filters.

Firm was issued a Form FD-483 for these and other minor deviations.
A response has been received in writing promising correction.

We are forwarding this EIR to HFD-332 for review and classification.

Delbert Porter, Supervisory
Investigator

DESTINATION (cc: HFD-332 w/exhibits; RFA-Z24 w/exhibits)

FORM FD 481 (4/75)

HEAZZY

d. DATE

10/6/76

PREVIOUS EDITION MAY BE USED UNTIL SUPPLY IS EXHAUSTED.

DOCUMENTS RELATING TO MORTON-NORWICH PRODUCTS, INC.

The enclosed recommendation for institution of a criminal action
against Morton-Norwich Products, Inc., and five of its officials
is somewhat unusual in that representatives of the company have
gone to great lengths to attempt to convince the Food and Drug Ad-
ministration and my office that criminal prosecution should not be
instituted. Not only has the company had an opportunity to make
its views known in accordance with established procedure pursuant
to 21 U.S.C. 335, but company representatives have on several oc-
casions met with the Food and Drug Administration on this matter.
Most recently, counsel for the company attempted to obtain still
another meeting to discuss the matter with my office. I concluded
that there had been enough meetings and discussion, and that further
meetings of this nature were not in the public interest. As a re-
sult, counsel for the company wrote me the enclosed letter dated
January 17, 1975, again setting forth their position on the matters
involved.

I believe it improper for me to continue this dialogue with the
company. It is apparent that there has been a clear and flagrant
violation of law, and a failure by the company and the named indi-
viduals to correct it once it was brought to their attention. Under
the circunstances, prosecution is certainly warranted. Accordingly,
I have responded to this most recent letter with a statement that
the matter would receive my detailed and personal scrutiny.
I can
assure you that this has been done.

Because I fully anticipate that counsel for the company will contact both the Department of Justice and you, to attempt to avoid prosecution, I asked a member of my staff to prepare a memorandum analyzing in detail the contentions made by counsel for the company in his letter of January 17. A copy of that memorandum is enclosed. I

believe that you will agree that it amply demonstrates the justification for criminal prosecution in this case. Because this is an internal memorandum, I would of course request that it not be disseminated outside the Department of Justice and the Food and Drug Administration.

Should you have any questions about this matter, I would be most happy to discuss it with you, and Mr. Blumberg, the attorney in my office who is assigned to this case, would be happy to meet with you and your staff at your convenience.

Sincerely yours,

Pain Berton Wutt

Peter Parton Hutt

Assistant General Counsel
Food and Drug Division

Enclosure

CC:

Gregory B. Hoverdon, Esq.

Chief, Consumer Affairs Section
Antitrust Division

Department of Justice

During the past several weeks, I`have sought to arrange a meeting with you or another representative of the General Counsel's office concerning a Notice of Hearing addressed to the Norwich Pharmacal Company and various individuals which issued this past April. In June, our office represented Norwich and the individuals at the informal hearing held in Buffalo, and, after that, at a follow-up meeting with Mr. Apodaca and Mr. Bryant. In November, Mr. Apodaca advised me that the Office of Compliance of the Bureau of Drugs had concluded that the matter should be referred to your office with a recommendation for prosecution. He suggested that if we hady reason to discuss the matter further we should communte with your office.

I telephoned Mr. Springer in December. He stated that the matter was, in fact, under consideration in the General Counsel's office but that any additional discussions concerning it would be "inappropriate." Mr. Springer suggested that if we had any further points to discuss, we should communicate them to you in writing or seek to discuss them later with representatives of the Department of Justice in the event the matter is referred forward for prosecution. Mr. Springer did meet with Mr. Becker and me on January 7, at which time we attempted to explain the reasons why such a meeting should be held. Mr. Springer, however, advised us that since we had had an opportunity on prior occasions (the informal hearing, and the meetings with Mr. Apodaca) to convince the FDA why prosecution should not be instituted, no further meeting was appropriate. Mr. Springer stated that the General Counsel's office was concerned primarily with determining whether the legal elements for a successful prosecution were present and assuring that the policy followed by the various Districts and Bureaus within the FDA is consistent.

In this regard, we noted the obvious fact that the FDA does not prosecute every violation, but undertakes such punitive action only where some additional factor, such as fraud,

deliberate deception, or gross or willful negligence is present. Mr. Becker and I advised Mr. Springer that we were unaware in this situation of any such factors that would indicate the need, or provide adequate policy justification for criminal prosecution of the firm or the individuals involved. We requested an opportunity to learn the underlying facts which the FDA views as the reason for the initiation of criminal action, so that we would have an opportunity to provide a specific response. We are not referring here to the facts which underlie the specific violations alleged in the citation notice, but to the reasons which lead the Agency to decide that this company and these individuals acted in a manner that requires criminal prosecution.

Mr. Springer advised us that if a recommendation for prosecution is forwarded a summary of those reasons would be provided in a letter from your office to the United States Attorney. He stated that the United States Attorney would then be free to discuss that background with us. Mr. Springer indicated, however, that your office, as a matter of policy, is not willing to discuss the underlying policy rationale for prosecution.

We regret very much the decision of your office not to discuss the total factual background, as perceived by the Agency, with us. It is our understanding that the history of Norwich has not been such as to indicate any disregard of the FDA or of the company's responsibilities under the Federal Food, Drug, and Cosmetic Act. The company's response to the citation hearing was based upon the facts as alleged to exist, and was designed to show that the company and each of the individuals involved had acted responsibly and in good faith. Whether or not the facts necessary for a successful criminal prosecution can be established in this case, we believe that no public benefit would be served by bringing such an action where the company and individuals involved have shown an adequate understanding of their duties and responsibilities.

If the company's understanding of the facts is at variance with yours, we believe that basic fairness dictates that the company be provided an opportunity to learn the Agency's version of the facts on which it has proposed to exercise its discretion. Only then could the company make a response, if one is available. Recognizing that the law permits the Agency wide discretion in the important function of recommending prosecution, fairness requires great care, including an opportunity to respond directly to the policy reasons as well as to the technical legal reasons, for the prosecution.