1Equipment and facility
Routine calibration of electronic equipment is not performed according to a written program designed to assure
Inspection Record
Jacobus Pharmaceutical Company, Inc. — FDA 483 Findings
Inspectors Atul J. AgrawalThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
FOR A TYPOGRAPHICAL ERROR.*** LABORATORY CONTROL SYSTEM
3Complaint and recall handling
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints and investigations conducted for each drug product.
4Complaint and recall handling
Written procedures are not established for evaluations dorie at least annually and including provisions for a review ofcomplaints and investigations conducted for each drug product.
5Stability and storage
Your stability testing program is not designed to monitor the stability characteristics of APis.
6Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
7Computer system validation
Appropriate controls are not established over computerized systems.
8Equipment and facility
Buildings used in the manufacture, processing, or holding ofdrug products are not maintained in a clean and sanitary condition.
9Deviation, CAPA, and investigation
Your firm's quality unit is not involved in quality-related matters; the unit fails to review deviations from established specifications or procedures and does not adequately assess the need for corrective actions for deviations it is made aware of.
10Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
11Deviation, CAPA, and investigation
Your firm’s quality unit is not involved in quality-related matters; the unit fails to review deviations from established specifications or procedures and does not adequately assess the need for corrective actions for deviations it is made aware of.
12Computer system validation
Appropriate controls are not established over computerized systems .
13Process validation
The process validation for a REDACTED (b)(4) increase in th e batch size REDACTED (b)(4)) of the active pharmaceutical ingredient PAS is inadequate.
14Stability and storage
All compounding and storage containers used during the production ofa batch ofdrug product is not properly identifi ed at all times to indicate the phase of processing ofthe batch.
15Stability and storage
All compounding and storage containers used during the production ofa batch of drug product is riot properly identified at all times to indicate the phase ofprocessing ofthe batch.
16Process validation
The process validation for a REDACTED (b)(4) increase in the batch size REDACTED (b)(4) of the active pharmaceutical ingredient PAS is inadequate.( (b) (4) The process validation for a R EDACTED (b)(4) increase in the batch size REDACTED (b)(4) of the active pharmaceutical ingredient PAS is inadequate.
17Equipment and facility
Buildings used in the manufacture, processing, or holding of drug products are not maintained in a clean and sanitary condition.
18Equipment and facility
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.
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.
