Inspections, Compliance, Enforcement, and Criminal Investigations
Shamrock Technologies 12-Dec-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 526-6004
December 12, 2001
RETURN RECEIPT REQUESTED
FILE NO.: 02-NWJ-13
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
New Jersey District Office