Inspection Record

RC Compounding Services, LLC — FDA 483 Findings

US FDAInspected 2015-11-13Published 2024-01-17 8 findingsAseptic processing and sterility assuranceEquipment and facilityTraining and personnel

View the regulator's official source The source document is always the basis for judgement.

Findings

1Aseptic processing and sterility assurance

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

2Equipment and facility

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

3Equipment and facility

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

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce a septic con ditions.

5Training and personnel

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

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

7Aseptic processing and sterility assurance

Procedures des igned to prevent microbiological contamination of drug products purporting to be sterile do not include v alidation of the sterilization process .

8Aseptic processing and sterility assurance

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

About this record

Extracted automatically from the document US FDA published on 2024-01-17. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2015-07-23 · US FDA · 6 findings2018-03-16 · US FDA · 6 findings
RC Compounding Services, LLC findings history — including this company's other documents US FDA documents, 2024 Go to Findings search