Grandpa's Compounding Pharmacy, Inc. — FDA 483 Findings

Laboratory records do not include a state of the location of data that establish that the methods used in the testing of the sa mple meet proper standards of accuracy and reliability as supplied to the product tested.

Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.

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

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

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written.

Equipment used in the manufacture, processing, packing orholding ofdrug products is n()t ofappropriate design to facilitate operations for its intended use.

Buildings used in the manufacturing and processing ofa dmg product are not maintained in a good state ofrepair.

Individuals responsible for supervising the manufacture and processing of a drug product lack the education, training, and experience to perform their assigned functi ons in such a manner as to assure the drug product has the safety, identity, strength , quality and purity that it purpo rts or is represented to possess.

Aseptic processing areas are deficient regarding air supply that is filtered through high-effiCiency particulate air filters under positive pressme.