Barclay Luke & Pillai Specialty Pharmacy PLLC dba Meta Pharmacy Services — FDA 483 Findings

Employees engaged in the manufacture and processing of a drug product lack the education, training and experience required to perform their assigned functions.

Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable construe tion to facilitate cleaning, maintenance, and proper operations.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

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

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

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

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

Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Examination of packaging and labeling materials for suitability and correctness before packaging operations is not performed and not documented in the batch production records.

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