Inspection Record

Hybrid Pharma LLC — FDA 483 Findings

US FDAInspected 2016-09-02Published 2024-01-17 9 findingsEquipment and facilityAseptic processing and sterility assuranceLaboratory and QC controlsDeviation, CAPA, and investigationStability and storageLabeling and packagingTraining and personnel

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

Findings

1Equipment and facility

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper perfo rmance .

2Aseptic processing and sterility assurance

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

3Laboratory and QC controls

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

4Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

5Stability and storage

There is no written testing program designed to assess the stability the characteristics of drug products.

6Aseptic processing and sterility assurance

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

7Labeling and packaging

The labels of your outsourcing facility's drug products are deficient.

8Training and personnel

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

9Aseptic processing and sterility assurance

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

2023-11-09 · US FDA · 11 findings2022-06-14 · US FDA · 6 findings2021-09-23 · US FDA · 7 findings
Hybrid Pharma LLC company profile — full history US FDA documents, 2024 Go to Findings search