1Aseptic processing and sterility assurance
Regarding aseptic operations: A.
Inspection Record
Sanofi Pasteur, Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
There is no assurance that training/ qualification ofall operators performing aseptic operations in the flu manufacturing area is complete.
3Aseptic processing and sterility assurance
On-going investigations into sterility failure investigations of 11 Influenza monvalent concentrate lots manufactured between 2/6/06 and 4/6/06 are deficient for the following reasons: A.
4Aseptic processing and sterility assurance
Vent filters on the de sterile influenza bulk concentrate tank, and onthe Ge dispensing siphon unit are not integrity tested.
5Validation and qualification
The following analytical method validations have not been finalized.
6Validation and qualification
The firm has a protocol for the qualification of solutions used in Manufacturing.
7Stability and storage
Corrective Actions have not been fully implemented for an identified root cause ofOOS stability results for physical exam of Bulk Td Adsorbed, Bulk Tripedia, BulkTd PF Adsorbed, Bulk DT PF, Bulk Flu, and Bulk Menactra.
8Aseptic processing and sterility assurance
Quality Assurance review ofbatch production records does not include an evaluation ofthe equipment sterilization records for sterile product contact equipment.
9Computer system validation
There is no adequate backup storage for the following master seed lots.
10Stability and storage
At time oflicensure, the stability program for Tripedia included testing ati ra ea The current stability program for Tripedia includes testing atMAM and expiry.
11Contamination control
Regarding bioburden testing ofin-process influenza vaccine: A.
12Equipment and facility
Thehepparplieltie Smoke Testing conducted as part ofthe Operational Qualification Testing for theLaminar Air Flow Unit # VLF-0067/68 Room 113, Building 37 was inadequate in thet the simulated dynamic operations were described only as “personnel within units”.
13Complaint and recall handling
Complaint investigations are not always completed in timely manner and there is no written justification for the lack oftimely completion.
14Stability and storage
Corrective Actions have not been fully implemented for an identified root cause ofOOS stability results for moisture ofthe Yellow Fever Vaccine for both 1 dose and 5 dose final containers.
15Other quality system
RERRAMSP owders were approved with an 18 month expiration date.
16Quality unit oversight
Annual Product Reviews (APRs) are not completed in a timely manner.
17Equipment and facility
There is no assurance that the wet/dry vacuum used for cleaning the floors ofclassified production areas prevents addition of bioburden inshethBdustion areas ifi that the HEPA filters on the unit are not routinely integrity tested and the interior drum where dirty solution is col...
18Stability and storage
The following OOSs occurred during the annual stability testing ofbulk products.
19Other quality system
Sampling ofthe reaction mixture during does not follow an appropriate procedure to prevent introductionof objectionable chemicals and microorganisms.
20Aseptic processing and sterility assurance
Monovalent influenza concentrate was sterile filtered into Q™% vessels without performing media simulations to determine the impact ofswitching from theee stainless steel tanks to the glass vessels.
21Complaint and recall handling
BPDRs were not filed for complaints ofglass in product.
22Aseptic processing and sterility assurance
Investigations to determine product impact are not performed when HEPA filter integrity or airfow failures are detected for any ofthe classified areas including Class A areas where aseptic filling, filtration, and formulation are performed.
23Material and supplier control
The purity, strength and quality ofsome critical components in manufacturing are not tested to validate the suppliers test results.
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.
