1Training and personnel
Clothing of personnel engaged in the manufacturing and processing ofdrug products is not appropriate for the duties they perform.
Inspection Record
Home Care Pharmacy of Palm Coast Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
3Deviation, CAPA, and investigation
Written records arc not made of investigations into unexplained discrepancies.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing and processing.
7Aseptic processing and sterility assurance
DATE(S)OF INS~CTION 5/17/2016- 5/25/2016* FEINU..,tK 3006899675 , St e A TYPE ESTABUSHt.ENT INSPECTED Producer of Sterile Drugs Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
