Microbiology FDA 483 (Precision Equine LLC): Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination
Observation
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product
Facility Type
Sterile & Non-Sterile Manufacturing
Firm / Company
Precision Equine LLC
System
Details
During walk-through of the facility on 8/23/2023, contamination was observed in your sterile and non-sterile areas for the following:
- Unknown yellow stains were observed on HEPA filters inside the ISO 5 LAFH used for producing sterile non-hazardous animal drug products in the Sterile Non-Hazardous Drug Suite.
- The frame of the HEPA filter inside the LAFH peeled off in the Sterile Non-Hazardous Drug Suite.
- Many white stains were observed on scales and walls of *** hoods *** used for producing non-hazardous drug products.
- Unknown stains were observed on a scale inside the *** hood used for compounding of sterile hazardous in the Sterile Hazardous Drug Suite.
- Unknown powders/residues were observed on a scale inside *** Hood *** used for producing non-sterile while the hood was not in use on that day.
- Opened drink cans and drink cups with visible liquid and spoons were discarded in trash bins in the non-sterile production area.
- A filter used to filter supply air inside the wall of the ISO 7 Negative Pressure Clean Room next to the ISO 5 BSC looked dirty with apparently visible debris in Sterile Hazardous Drug Suite.
Record Date
01/2024
FEI Number
3005698544
Country
California
Citation Type
483
Audit Duration (Days)
9
Investigators
Taichun Qin, Sara H Gabel, Julia N. Alvarez
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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.
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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
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Computerized System
4
Contamination
13
Contemporaneous Verification
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Data Integrity Issue
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Disinfectant Efficacy
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Disinfection
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Drug Product
1
Endotoxin
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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
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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
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