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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Neogen Corporation 06-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

6751 Steger Drive

Cincinnati, OH 45237-3097

December 6, 2001

WARNING LETTER CERTIFIED MAIL

CIN-02-WL-11563 RETURN RECEIPT REQUESTED

James Herbert,

President ancl CEO

Neogen Corporation

620 Lesher Place

Lansing, MI 48912

Dear Mr. Herbert:

During an inspection of your veterinary drug manufacturing facility, Neogen Corporation, located at 2040 Creative Dr., Suite 400, Lexington, KY 40505, conducted on November 16, 2001, our investigator found significant deviations from the regulations for Current Good Manufacturing Practice for Finished Pharmaceuticals (Title 21, Code of Federal Regulations, Part 211). These deviations cause the animal drugs manufactured at this facility to be adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act, Section 501 (a)(2)(B).

Our inspection found:

(1) Failure to validate the manufacturing process and controls for the manufacture of

Spec-Tuss™ Palatable Expectorant Powder (Active ingredient: guaifenesin) to assure

they will produce drug products that have the identity, strength, quality and purity

they purport or are represented to possess. [21 CFR 211.100]

FDA?s Internet site contains a Guideline on General Principles of Process Validation

which can be found at: http://www.fda.gov/cder/guidance/pv.htm

(2) Failure to establish stability data to support the 2 year expiry period for Spec-Tuss™

Expectorant Powder. [21 CFR 211.166]

(3) Failure to use a validated test method for release testing. The assay method for

guaifenesin in Spec-Tuss™ Palatable Expectorant Powder has not been validated for

accuracy, sensitivity, specificity and reproducibility. [21 CFR 211.165(e)]

(4) Failure to document QA review and approval of production and control records prior

to release for distribution of Spec-Tuss™ Powder lot 0908012. [21 CFR 211.192]

(5) Failure to maintain complete information in batch production and control records.

White-out was used to change recordings on Label Accountability and Fill

Reconciliation pages of the batch record for Spec-Tuss™, lot 0908012, thereby

obscuring the original recordings. [21 CFR 211.188]

Errors on batch production, control and lab records must not be erased or overwritten

(interpret as no whiteout). A line must be drawn through an incorrect entry and the

corrected figure or word written neatly and initialed. Significant data must not be

discarded without explanation. To discard significant data, the data must be crossed

out, initialed, and a valid reason for discarding the data explained.

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.

We acknowledge our receipt of a November 30, 2001 response letter to the November 16,

2001 Inspectional Observations (Form FDA-483), received from Shannon Bass, Director of Operations, Veterinary Products. Please provide documentation for our review which will verify the adequate completion of the promised corrections by the dates specified. If

corrections cannot be completed by the specified dates, state the reason for the delay and the time within which the corrections will be completed.

The above is not intended to be an all-inclusive list of the violations at this facility. As a

manufacturer of veterinary drugs, you are responsible for assuring that your overall

operation and the products which you manufacture are in full compliance with the law. This includes assuring that your manufacturing process and controls, test methods, and expiration dates are valid. Your response uses the excuses that the manufacturing rights to this product were purchased from another company and you lacked of knowledge that the test method was not validated. This in no way negates your responsibilities. The Certificate of Analysis from the invalidated test method specifically states that "The method(s) used are not validated" and "Results are for your information only". It is your responsibility to assure and verify that your suppliers and contract laboratories are providing appropriate raw materials, labeling, packaging and testing services.

Your documentation of corrections should be directed to Charles S. Price, Compliance

Officer, U.S. Food & Drug Administration, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have any questions, you may call Mr. Price at (513) 679-2700, extension 165.

Sincerely,

District Director

Cincinnati District Office