Unico Holdings, Inc. — FDA 483 Findings

Failure to take effective measures to protect against the inclusion of extraneous material in food.

A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated and approved according to established procedures.

Failure to locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food.

Failure to remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures.

Washing and toilet facilities are not provided and easily accessible to working areas.

Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

Failure to inspect, segregate, and handle raw materials to ascertain that they are clean and suitable for processing into food.

Failure to provide hand washing facilities at each location in the plant where needed.

Failure to perform filling, assembling, and packaging in a manner that protects food from becoming contaminated.

Routine inspection and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.

The plumbing system contains defects that could contribute to the contamination of drug products.

Appropriate training in food handling techniques and food protection principles has not been provided to food handlers and supervisors.

For components removed from the original containers, the new container fails to be identified with component name or item code, weight or measure, and batch for which component was dispensed including product name, strength and lot number.

Failure to store finished food under conditions that would protect against deterioration of the food and its container.

All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.

Failure to provide adequate screening or other protection against pests.

Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination.

Failure to perform mechanical manufacturing steps so as to protect food against contamination.

Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.