1Contamination control
Separate or de fined areas to prevent contamination or mix-ups are deficient regarding the packaging and labeling operations.
Inspection Record
Coastal Meds, LLC. — FDA 483 Findings
Inspectors Marvin D. JonesThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
There is a fai lure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or no t the batch has been already distributed.
3Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to faci litate cleaning, maintenance, and proper operations.
4Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance t o such requirem ents.
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.
