Pine Pharmacy and Home Care Products Center, Inc — FDA 483 Findings

Results of stability testing are not used in determining expiration dates Specifically, prescription #REDACTION (b)(6) for Cyclosporin 1% Ophthalmic, sterile veterinary dru g the processing record shows an ingredien t used-Adjuvants Stock for Cyclosporin (a) ey e drop wi th an expiration date of 12/24/13.

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

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

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

Employees are not given training in the particular operations they perform as part of their function.

An adequate number of batches of each drug product are not tested nor are records ofsuch data maintained to determine a n appropriate expiration date.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate des ign to facilit ate operations for its intended u se .

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.