1Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Inspection Record
Med Shop Total Care Inc. — 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
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Laboratory 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.
4Process 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.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Laboratory and QC controls
Each batch of drug product required to be free ofobjectionable microorganisms is not tested through appropriate laboratory testing.
7Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
8Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
9Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing and holding of chug products is not appropiate for the duties they perform.
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.
