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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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ImmuCell Corporation 01-Jun-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896




WARNING LETTER

NWE-20-07W

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

June 1, 2007

Michael Brigham, President and Chief Executive Officer
ImmuCell Corporation
56 Evergreen Drive
Portland, Maine 04103

Dear Mr. Brigham:

An investigation of your pharmaceutical manufacturing facility located at 56 Evergreen Drive, Portland, Maine, by representatives from the U.S. Food and Drug Administration (FDA) on October 10-23, 2006, confirmed that you are manufacturing and marketing Wipe Out® Dairy Wipes.

Under 201(g) [21 U.S.C. § 321(g) of the Federal Food, Drug, and Cosmetic Act (the Act), any article "intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" or "articles (other than food) intended to affect the structure or any function of the body of man or other animals" is defined as a drug. Because you market this product as being intended for use in the prevention of mastitis, including being proven effective at killing mastitis causing organisms, this product is a drug under section 201(g) [21 U.S.C. § 321(g)] of the Act. In addition, we are not aware of any evidence that this product is generally recognized by qualified experts as safe and effective for its intended use. Therefore, this product is also a new animal drug under section 201 (v) [21 U.S.C. § 321(v)] of the Act.

Your product is adulterated within the meaning of section 501(a)(5) (21 U.S.C. § 351 (a)(5)] of the Act, in that it is a new animal drug which is unsafe within the meaning of section 512(a) (21 U.S.C. § 360b(a)] of the Act. A new animal drug is considered to be unsafe unless there is an approved new animal drug application (NADA) for the product. Your Wipe Out® Dairy Wipes product is not covered by an approved NADA.

This causes the product to be unsafe within the meaning of section 512(a) [21 U.S.C. § 360b(a)] of the Act and, thus, adulterated pursuant to section 501(a)(5) [21 U.S.C.§ 351 (a)(5)] of the Act.

You can find the Act and its associated regulations on the Internet through the links on the FDA web page at www.fda.gov.

Furthermore, the inspection revealed serious deviations of the current good manufacturing practices (cGMP) regulations for the manufacture of finished pharmaceuticals in Title 21, Code of Federal Regulations, Parts 210 and 211 (21 C.F.R. Parts 210 and 211). These cGMP deviations cause your firm's finished pharmaceutical product to be adulterated within the meaning of section 501(a)(2)(B) [21 U.S.C.§ 351 (a)(2)(13)] of the Act. Section 501 (a)(2)(B) [21 U.S.C. § 351(a)(2)(B)] of the Act requires that the methods used in, or the facilities or controls used for, the manufacturing, processing, packing, and holding of drugs be in conformity with cGMP regulations.

The deviations from the cGMP regulations include, but are not limited to:

• Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. [21 C.F.R. § 211.137].

• Laboratory controls do not include the establishment of scientifically sound and appropriate standards or specifications designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity. [21 C.F.R. § 211.160(b)].

• Sampling and testing plans for drug products are not described in written procedures which include the method of sampling. [21 C.F.R. § 211.165(c)].

The above are not intended to be an all-inclusive list of violations that exist at your facility. It is your responsibility to ensure that your overall operation and the products marketed by your firm are in compliance with the Act and its implementing regulations.

We acknowledge receipt of a letter addressed to Mr. Bruce R. Ota, Compliance Officer, FDA/New England District, dated January 18, 2007, that was written on your behalf by Mr. Robert C. Wilder, Director of Quality and Regulatory Affairs, in response to the Form FDA-483, Inspectional Observations, issued to you on October 23, 2006. We have reviewed your response and concluded that, it does not adequately address the inspectional observations. For example, most items are not directly addressed, actual methods and data were not supplied, studies that have been conducted do not use enough samples for meaningful analysis and leave as many questions unanswered as they address, and timeframes for completion of corrections are lengthy.

You should take prompt action to correct these violations and to establish procedures to prevent their recurrence. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. Also, federal agencies are routinely advised of the issuance of warning letters so that they may take this information into account when considering the award of contracts. Additionally, New Animal Drug Applications for products to which the cGMP regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject drugs have been corrected.

You should notify this office in writing with fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrections cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed. Also include copies of any available documentation demonstrating that corrections have been made.

Your reply should be directed to Bruce R. Ota, Compliance Officer, Food and Drug Administration, One Montvale Avenue, 4th Floor, Stoneham, Massachusetts 02180. If you have any questions you can contact Mr. Ota at the above phone number.

Sincerely,

/S/

Gail T. Costello
District Director
New England District