Drugs

17 Observations on Empower Pharmacy FDA-483

FDA has released the form FDA-483 issued following a 7/18-8/5 inspection at Empower Clinical Services, doing business as Empower Pharmacy, a Houston, TX, outsourcing facility. The 17 inspection observations were:

failing to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit;
failing to establish, write, and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
failing to establish and follow written procedures that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch;
failing to have written procedures describing in sufficient detail the receipt, handling, sampling, testing, approval, and rejection of components;
procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the aseptic process;
laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality, and purity;
drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use;
testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient before release;
the outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six-month period;
adverse drug experience information has not been reported to FDA;
the labels of the outsourcing facility’s drug products are deficient;
failing to establish and follow written procedures for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected; and
bulk drug substances used by the outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under Section 510 as required by Section 503B(a)(2)(C).

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