1Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the duties they perform.
Inspection Record
Coastal Meds, LLC. — FDA 483 Findings
Inspectors Claire M. MindenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
3Regulatory reporting and change control
Your outsourcing facility has not submitted product reports to FDA as required by section 503B(b)(2)(A).
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Complaint and recall handling
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions .
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
8Labeling and packaging
The labels of some of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A)and (B).
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.
