Inspection Record

I.V. Specialty Ltd. — FDA 483 Findings

US FDAInspected 2016-09-01Published 2024-01-17 8 findingsAseptic processing and sterility assuranceEquipment and facilityTraining and personnelDeviation, CAPA, and investigation

Inspectors Massoud Motamed · Shelby N. MarlerThe inspectors who signed the published document.Inspector lookup

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

Findings

1Aseptic processing and sterility assurance

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

2Aseptic processing and sterility assurance

Procedures des igned to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.

3Equipment and facility

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

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

5Training and personnel

Clothing of personnel engaged in the manufacturing, processing, packing, and holding ofdrug products is not appropriate for the duties they perform.

6Aseptic processing and sterility assurance

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

7Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

8Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental 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

2017-09-12 · US FDA · 3 findings
I.V. Specialty Ltd. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search