1Quality unit oversight
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
Inspection Record
CP Pharmaceuticals — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Reserve samples from representative sample lots or batches ofdrug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that components, drug product containers, and closures conform to appropriate standards of identity, strength, quality and purity.
4Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
5Training and personnel
Employecs cngaged in the processing of a drug product lack the training required to perform their assigned functions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product arc not followed.
9Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
10Material and supplier control
Representative samples are not taken of each shipment of each lot of components, drug product containers, and closures for testing or examination.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
12Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended usc.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2017-01-27. 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.
