1Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Inspection Record
Pharmacy Plus, Inc. dba Vital Care Compounder — 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
2Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
3Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable size to facilitate cleaning, maintenance, and proper operations.
4Laboratory and QC controls
The written stability program for drug products does not include meaningful and specific test methods.
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.
6Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform.
7Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
8Equipment and facility
Records are not kept for the maintenance, sanitizing and inspection of equipment.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2019-07-12. 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.
