Microbiology FDA 483 (Front Door Pharmacy): The use of sporicidal agents in aseptic processing area was inadequate
Observation
The use of sporicidal agents in the cleanrooms and ISO 5 classified aseptic processing area was inadequate
Facility Type
Sterile Manufacturing
Firm / Company
Front Door Pharmacy, LLC
System
Quality System, Laboratory Controls, Facility and Equipment System
Details
Specifically, your firm failed to validate the sporicidal agent, *** Sporicidal Disinfectant Cleaner for its intended use within the cleanroom and aseptic production processing area.
Record Date
03/2024
FEI Number
3012937475
Country
Texas
Citation Type
483
Audit Duration (Days)
9
Investigators
Camerson E Moore
More observations from same firm / company
FDA 483 relevant to Microbiology
Disclaimer: The purpose of this article is to provide helpful information on FDA 483s related to microbiological issues. This article represents 483 information in Tabular form for quick access and easy navigation. Information for this article is derived from “Form FDA 483” (Inspectional Observation). This article is not intended to replace the information provided by the FDA, nor is it guaranteed to be complete, always refer official FDA site for details.
More Observations...
Alarm
1
Aseptic Behavior
30
Aseptic Technique
49
Autoclave
1
Biological Indicator
1
Building Maintenance
6
Calibration
1
Clean Room
15
Clean Room Practices
36
Cleaning and Sanitization
29
Cleaning Validation
1
Computerized System
4
Contamination
13
Contemporaneous Verification
1
Data Integrity Issue
10
Disinfectant Efficacy
2
Disinfection
15
Drug Product
1
Endotoxin
1
Environment monitoring
16
Equipment Cleaning
6
Equipment Operation
13
Facilities And Equipment System
13
Facility Design
5
Follow-Up Findings
2
General Cleaning
3
Good documentation Practices
4
Gowning
3
HEPA
4
Hold Time Study
2
HVAC
6
Influx of lesser quality air
1
Investigation
12
Investigation inadequate
5
Investigation incomplete
3
Laboratory Controls
17
Laboratory Practice
16
Maintenance
10
Manufacturing control
9
Media Fill
15
Method Transfer
2
Method Validation
5
Microbial Identification
1
Microbiological Contaminationn
10
No Procedure followed
14
Non-Conformance
1
OOS
5
Personnel Monitoring
3
Procedure
32
Qualification
32
Quality System
33
Risk assessment
6
Service Vendor Audit
1
Smoke studies
14
Specifications
5
Stability Study
2
Sterile Drug Products
5
Sterility Testing
1
sterilizati
2
Sterilization
3
Suitability
1
test procedure
0
Test Procedure (SOP)
10
Trends
1
Usage log
1
Validation
37
Visual Inspection
1
Warehouse
2
Water System
1
Jiangsu Hengrui Pharmceuticals Co., Ltd
Your container closure integrity test for *** Injection (USP) ***mg/***ml is inadequate, The test used empty vials instead of fille vials. Microbial Challenge Study was conducted without a positive control. Dye ingress study was conducted using human eye detection with results "not detected" without specifying the limit of detection,
Jiangsu Hengrui Pharmceuticals Co., Ltd
Product contact equipment including *** stopper drums, *** were sterilized without outer wrapping and transferred from Grade A cart to Inside of the RABS without cover in Workshop *** Filling Room ***.
Jubilant DraxImage Radiopharmacies Inc.
Specifically, on 03/06/24, during the production of Gozetotide (Illucix) Cold Kit Lot# K-***, your firm's Pharmacy Manager was observed blocking first pass air in the ISO-5 *** flow hood. The following prescriptions were drawn from the cold kit and dispensed: RX*** (13.94 mCi) and RX*** (25.49 mCi).
Jubilant DraxImage Radiopharmacies Inc.
Specifically, on 03/06/24, during the production of Gozetotide (Illucix) Cold Kit Lot# K-***, your firm's Pharmacy Manager was observed performing the following aseptic connections in the ISO-7 aseptic processing area: connecting the *** sterile *** to the Gallium Generator and connecting the Sterile *** to the Gallium Generator. The following prescriptions were drawn from the cold kit and dispensed: RX*** (13.94 mCi) and RX*** (25.49 mCi).
Eugia Pharma Specialities Limited
Surface monitoring of the filling and stoppering machine is not performed in a timely manner following the completion of aseptic filling operations to ensure the data is representative of the environmental conditions at the time of filling. For example:
Eugia Pharma Specialities Limited
On April 29, 2024, *** cleaning wipes packed and ready to be used for *** aseptic cleaning in the Grade A area of the *** Injection *** filling line *** had loose threads and fibers them. The same wipes are also used for *** cleaning in the *** Injection manufacturing line ***. Upon receiving, the wipes are not inspected for the presence of loose threads and fibers.