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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Custom Manufacturing Corporation 27-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
555 Winderley Pl., Ste. 200
Maitland, FL 32751

VIA FEDERAL EXPRESS
WARNING LETTER
FLA-02-16
November 27, 2001

David R. Wilpon, President
Custom Manufacturing Corporation
9771 NW 91st Court
Medley, FL 33178

Dear Mr. Wilpon:

During an inspection of your facility located in Medley, Florida on May 23rd and 30th, 2001, FDA Investigator Victor Spanioli found that your firm is manufacturing and marketing veterinary products including CortiSpray Therapeutic Spray, OtiCalm Cleansing Solution, and ChlorhexaDerm Shampoo. These products are labeled and promoted for conditions or contain ingredients which cause them to be considered drugs within the meaning of Section 201 (g) of the Federal Food, Drug, and Cosmetic Act (the Act).

This inspection revealed that these drugs are adulterated within the meaning of section 501(a) (2) (B) of the Act in that they are veterinary drugs and the methods used in, or the facilities or controls used for, their manufacture, processing, packing or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice (GMP) regulations for drugs specified in Title 21 CFR, Part 211 as follows:

Failure to perform identity tests for raw materials or to verify the validity and accuracy of certificates of analyses received from suppliers;

Failure to validate the manufacturing processes used to manufacture veterinary drug products;

Failure to validate the DI/purified water system or the equipment cleaning procedures;

Failure to establish a stability program or have documentation supporting the expiration dates for veterinary drug products; and,

Batch production records are incomplete in that they are not properly initialed, lack necessary information, or contain discrepancies that are not addressed.

We are in receipt of your response dated July 18th, 2001, to the list of Inspect ional Observations (FD-483) left with you at the close of the inspection. We do not consider the response adequate because it failed to list corrective actions requested in response to the three observations verbally discussed at the close of the inspection, two of which are listed above; test results mentioned in the response to observation number 3 were not attached; and, the timeframes listed for completion of the corrective actions appear to be excessive.

Also discussed with you during the inspection were discrepancies found in the labeling of cosmetic products contract manufactured by your firm for other distributors. Please include in your response to this letter all corrective actions taken by your firm to correct these discrepancies.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It remains your responsibility to ensure adherence to each requirement of the Act and regulations.

You should take prompt action to correct these violations. Federal agencies are advised of the issuance of all Warning Letters so they may take this information into account when considering the award of contracts. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties.

Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct these violations and to prevent the recurrence of similar violations. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which corrections will be completed.

Your response should be sent to the Food and Drug Administration, Florida District Office, 555 Winderley Place, Suite 200, Maitland, Florida 32751, Attention: Martin E. Katz, Compliance Officer.

Sincerely,
Emma R. Singleton
Director, Florida District