1Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
Inspection Record
MedPREP Consulting Inc. — FDA 483 Findings
Inspectors Jose M. Cayuela · Russell Glapion · James A. LiubicichThe 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
Separate or defined areas to prevent contammation or mix-ups are deficient regarding the manufacturing and processing operations.
3Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.
4Other quality system
Written procedUres are not drafted.
5Documentation and records
Master production and control records lack complete manufacturing and control instructions and s ampling and testing prooedures.
6Equipment and facility
Equipment used in themanufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products putporting to be sterile are not established, written, and followed.
8Training and personnel
Clothing ofpersonnel engaged in the manufitcturlng and processing ofdrug products is oot appropriate for the duties they pewm.
9Labeling and packaging
Reserve drug product samples are not retained and stored under conditions consistent with product labeling.
10Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards ofidentity, strength, quality and purity.
11Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to t heet any of its specifications whether or not the batch has been already distributed.
12Environmental monitoring
work in a REDACTION (b)(4) square foot cleanroom .
13Equipment and facility
The operations relating to the processing and packing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.
14Equipment and facility
Written procedures for cleaning and maintenance filii to·include maintenance and cleaning schedules, description in sufficient detail ofmethods, equipment and materials used, instructions for protection ofclean equipment from contamination prior to use, and parameters relevant to the operation.
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.
