FDA 483 - BMD Skincare, Inc. - March 05, 2019

This FDA Form 483 documents observations from an inspection of a facility producing drug products. The facility lacks a written testing program for assessing drug product stability, and stability studies are not conducted to determine expiration dates. Instead, expiration dates are based on the earliest raw material expiration or two years from production, whichever is shorter. There are no batch records to confirm that drug products used for stability studies match distributed products in formulation and container closure systems, and stability reports lack product lot numbers, only referencing formulation numbers. Investigations into stability sample failures were not conducted.

The quality control unit's responsibilities and procedures are not in writing or fully followed. Components are not withheld from use until sampled, tested, examined, and released by QC. The firm failed to confirm the suitability of REDACTED for non-sterile drug product production. Components are not handled and stored to prevent contamination, and each component is not tested for conformity with written specifications for purity, strength, and quality. Suppliers of drug substances are not qualified.

Laboratory controls lack scientifically sound test procedures to assure drug product conformity. Preservative effectiveness testing has not been conducted to ensure adequate preservative levels through expiration. Manufacturing equipment is not of appropriate design, size, or suitable location. Batch production and control records are incomplete, and samples taken for conformance testing are not representative. The facility compounds drugs that are essentially copies of approved drugs. Labels and containers of the outsourcing facility's drug products do not include required information per section 50