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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shamrock Technologies 12-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Central Region

Food and Drug Administration

Waterview Corporate Center

10 Waterview Blvd., 3rd Floor

Parsippany, NJ 07054

Telephone (973) 526-6004

December 12, 2001

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

FILE NO.: 02-NWJ-13

William Neuberg

Owner

Shamrock Technologies, Inc.

117 Docks Comer Road

Dayton, New Jersey 08810

Dear Mr. Neuberg:

On October 24, 25, 29 and 31, 2001, the U.S. Food and Drug Administration conducted

an inspection of your facility located at Foot of Pacific Street Newark, New Jersey.

During the inspection our investigator documented significant deviations from the

Current Good Manufacturing Practices Regulations (cGMPs) Title 21, Code of Federal

Regulations, Part 210 and 211, in conjunction with your firm?s manufacture of

veterinary drug products.

The inspection revealed that veterinary drug products manufactured at your facility are

adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug and

Cosmetic Act (the Act), in that the methods used in, or the facilities or controls used for

their manufacture, processing packing or holding do not conform with cGMPs, to

assure that such drug products meet the requirements of the Act The deviations were

presented to you on a FDA483, List of Inspectional Observations, at the close of the

inspection on October 31, 2001.

The significant observations are as follows:

1. No assurance that the veterinary drug products Androhep Plus and Androhep Lite

are not contaminated with various industrial products Your firm manufactures

waxes, polyterafluoroethylene and polyethylene/poltetrafluoroethylene mixes for

the Ink and coating industries in the same blender, [redacted] as the above

referenced veterinary drug products. Your firm does not have validated cleaning

procedures for Androhep Plus and Androhep Me and does not perform any

testing on the veterinary drug products for the presence of industrial products.

2. The manufacturing process for the products Androphep Plus and Androhep Lite is not validated. Your firm has no documentation to support the manufacturing parameters, the order and amount of components, and blending time used to manufacture the finished veterinary drug products.

3. Your firm fails perform any testing or receive a Certificate of Analysis (COA) to verify the identity to the active raw materials, Gentamicin sulfate and Neomycin Sulfate, which are used in the manufacture of the finished veterinary drug products Androhep Plus and Androhep Lite.

4. Failure to store the finished product Androhep Plus and Androhep Lite (100 kg drums), as per the temperature conditions states on the product label. The product label states "Store at 2-8 degrees C". The finished product was stored at room temperature [redacted] for 3 to 4 days prior to shipping.

5. The raw materials used for the products Androhep Plus and Androhep Lite are not to be used in the manufacture of drug products. The COA for the Gentamicin Sulfate (faxed to your firm at the request of our investigator) states "For research use only" and "Not for human or drug use" and the Safety Information for the Base Powder, Buffer AP, states "May CAUSE HARM TO THE UNBORN CHILD" AND " MAY CAUSE CONGENITAL MALFORMATION IN THE FETUS".

If you intend to produce any API?s or drug products, you should notify this office in

writing within 15 working days of receipt of this letter, of any corrective actions,

including an explanation of each step being taken to prevent the recurrence of similar

conditions. If corrective action cannot be completed within 15 working days, state the

reason for the delay. Your reply should be sent to the Food and Drug Administration,

New Jersey District Office, 10 Waterview Blvd, 3rd Floor, Parsippany, New Jersey

07054, Attention Andrew Ciaccia, Compliance Officer.

Very truly yours,

Douglas L. Ellsworth

District Director

New Jersey District Office