RAM Pharma, Inc. — FDA 483 Findings

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

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 t o produce aseptic conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written or followed.

The drug product report your outsourcing facility submitted to the FDA as required as by section 503B (b) (2) ( A) is not accurate.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not i nclude adequate validation of the sterilization process.

The labels of your outsourcing facility's drug products do not include information required by sections 503B9a) ( 10) (A) and (B).

Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine c onformance to such requirements.

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

There is no quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.