Inspection Record

Delta Pharma, Inc. — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 8 findingsAseptic processing and sterility assuranceEquipment and facilityMaterial and supplier controlTraining and personnel

Inspectors Zada L. GilesThe 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 air supply that is filtered through high-efficiency particulate air filters under positive pressure.

2Equipment and facility

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

3Material and supplier control

Each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.

4Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation of the sterilization process.

5Aseptic processing and sterility assurance

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

6Aseptic processing and sterility assurance

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

7Equipment and facility

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations fo r its intended use.

8Training and personnel

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

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

2024-04-12 · US FDA · 3 findings2024-04-03 · Health Canada · 7 findings2024-04-03 · Health Canada · 12 findings2018-06-08 · US FDA · 9 findings2018-10-24 · US FDA · 6 findings2022-05-20 · US FDA · 5 findings
Delta Pharma, Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search