Martin Avenue Pharmacy, Inc. — FDA 483 Findings

Procedmes designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe ster ilization process.

Batch production and control records do not include complete information relating to the production and control of each batch.

There is no written testing program designed to assess the stability characteristics ofdrug products.

Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing or holding ofa drug product.

There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.

The control systems necessary to prevent contamination or mix-ups are deficient.

Equipment surfuces that contact components and in-process materials are reactive, additive or absorptive so as to alter the safety, identity, strength, qual ity, or purity ofthe drug product beyond the official or other established requirements.

Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

During a field examination ofdrug products at your fac ility the following was observed: Specifically, On 6/30/2014 I observed a vial of sterile injectable human drug product Bi-Mix (30mg Papaverine/1 mg Phentolamine/1 ml) RED ACTION (b)(6) with a black particle in it.

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 ofthe drug product.

Time limits are not establ ished when appropriate for the compl etion of each production phase to assure the quality of the drug product.

Reports ofanalysis from component suppliers are accepted in lieu oftesting each component for confonnity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of t he supplier's analyses through appropriate validation ofthe supplier's test results at appropriate intervals.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.

Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.

Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination ofthe drug product Specifically, On 7/2/2014 I observed the sterile human drug product Acety!cysteine (Preservative F...