Inspection Record

Bedford Pharmacy Inc. — FDA 483 Findings

US FDAInspected 2016-09-01Published 2024-01-17 6 findingsLaboratory and QC controlsAseptic processing and sterility assuranceStability and storage

Inspectors Stacey S Degarmo · John P MistlerThe 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 determinatio n of satisfactory conformance to the identity and strength of each active ingredient prior to release.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

4Stability 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.

5Laboratory and QC controls

Each batch of drug product required to be free ofobjectionable microorganisms is not tested throug h 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.

Bedford Pharmacy Inc. company profile — full history US FDA documents, 2024 Go to Findings search