1Equipment and facility
Buildings used in the manufacturing, processing, packing, and holding ofa drug product are not maintained in a good state of repair.
Inspection Record
Hospira, Inc. — FDA 483 Findings
Inspectors Sharon K. Thoma · Sina Shojaee · Lucas B. LeakeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Representative samples are not taken ofeach shipment ofeach lot ofcomponents for testing or examination.
3Laboratory and QC controls
Drug product container and closure test procedures are deficient in that closures are not tested for conformance in accordance with appropriate written procedures.
4Complaint and recall handling
An NDA-Field Alert Report was not submitted witbin three working days of receipt ofinformation concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
5Laboratory and QC controls
Each batch ofdn1g product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
6Equipment and facility
The calibration ofinstruments is not done at suitable intervals in accordance with an established written program.
7Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strcngUt, quality, and purity they purport or are represented to possess.
8Complaint and recall handling
Procedures describing the handling ofall written and oral complaints regarding a drug product are not followed.
9Laboratory and QC controls
Laboratory controls do not include the establishment"ofscienrifica11y sound and appropriate test procedures designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and puritY.
10Equipment and facility
Written records ofmajor equipment maintenance are not included in individual equipment logs.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
12Other quality system
Reserve drug product samples are not representative ofeach lot or batch ofdrug product.
13Equipment and facility
Washing and toilet facilities are not easily accessible to working areas.
14Training and personnel
Employees engaged in the manufacture, processing, packing, and holding ofa drug product Jack the training and experience required to perform their assigned functions.
15Material and supplier control
There is a failure to thoroughly review the failure ofa batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.
16Equipment and facility
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
17Material and supplier control
Each lot in each shipment received was not identified with a <tistinctive code for each container or grouping of containers for components.
18Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time ofuse.
19Process validation
Written procedures are not followed that describe the in-process controls, test~.
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.
