In Your Atmosphere Holdings LLC, (dba Highland Pharmacy) — FDA 483 Findings

Your firm failed to routinely calibrate, inspect or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspection of automatic , mechanical or electronic equipment.

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug product containers, in-process m aterials, and drug products conform to appropriate standards of identity, strength, quality and purity.

Employees are not given training in current good manufacturing practices (GMP).

Writen procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

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

The responsibilities and procedures applicable to the quality control unit are not in writing.