1Other quality system
There is no testing to assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use.
Inspection Record
JCB Laboratories LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established or followed.
3Labeling and packaging
The labels used on your compounded drug products are incorrect as follows: Specifically, A Currently the label states "FDA.gov/medwatch or 1-800-FDA-1088" which is not the web address given in section 503B(a) (10) (B)(ii) ...
4Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Documentation and records
Batch production and control records do not include complete labeUng control records, including specimens or copies of all labeling used for each batch of drug product produced.
7Equipment and facility
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
8Process validation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics ofin-process material and the drug product.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
