Inspection Record

Nora Apothecary and Alternative Therapies, Inc. — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 6 findingsLaboratory and QC controlsEquipment and facilityAseptic processing and sterility assuranceStability and storage

Inspectors Larry K. Austin · Marie A. FaddenThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory 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.

2Equipment and facility

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a dmg product.

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

4Stability and storage

There is no written testing program designed to assess the stability characteristics ofdrug products.

5Laboratory and QC controls

Each batch of drug product requred to be free of objectionable migroorganisms is not tested through appropriate laboratory testing.

6Aseptic 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 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.

Other records for this company

2015-07-10 · US FDA · 6 findings
Nora Apothecary and Alternative Therapies, Inc. company profile — full history US FDA documents, 2024 Go to Findings search