1Complaint and recall handling
you had numerous complaints ofthe same label defect.
Inspection Record
Hospira Inc. A Pfizer Company — FDA 483 Findings
Inspectors Carl A. Huffman · Shafiq S. Ahadi · Michele Perry-Williams and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The acceptance status of product was not identified to indicate conformance or nonconformance with acceptance criteria Specifically, you did not identify by suitable means, the acceptance status of product, to indicate the conformance or nonconformance with acceptance criteria.
3Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
4Material and supplier control
Labeling or packaging materials which did not meet written specifications were not rejected to prevent their use in operations for which they are unsuitable.
5Material and supplier control
Rejected in-process materials are not controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable.
6Other quality system
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
7Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
9Other quality system
You did not notify the agency of the changes in a drug product container closure system that controls the drug product delivered to a patient or changes in the type (e.g., glass to Redacted (b) (4)
10Other quality system
In-process specifications are not consistent with drug product final specifications, derived from previous acceptable process average and process variability estimates where possible or determined by the application of suitable statistical procedures where appropriate.
11Validation and qualification
A written record of the program along with appropriate validation data has not been maintained in situations where Redacted (b) (4).
12Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence ofdeterioration.
13Complaint and recall handling
An FDA Field Alert was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches ofa drug to meet the specifications established for it in the application.
14Deviation, CAPA, and investigation
Written records ofinvestigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
15Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2021-04-21. 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.
