Inspection Record

Atlas Pharmaceuticals, LLC — FDA 483 Findings

US FDAInspected 2017-09-26Published 2019-12-09 9 findingsLaboratory and QC controlsAseptic processing and sterility assuranceEquipment and facilityTraining and personnelStability and storageLabeling and packaging

Inspectors Stephanie A SlaterThe 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

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components, in-process materials and drug products confonn to appropriate standards of identity, strength, quality and purity.

2Aseptic processing and sterility assurance

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

3Equipment and facility

There is a lack of written procedures describing in sufficient detail the methods, equipment and materials to be used for sanitation.

4Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

5Training and personnel

Employees engaged in the manufacture, processing, packing and holding of a drug product Jack the education, training and experience required to perform their assigned functions.

6Laboratory and QC controls

Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.

7Stability and storage

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

8Stability and storage

Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.

9Labeling and packaging

The labels ofyour outsourcing facility's drug products are deficient.

About this record

Extracted automatically from the document US FDA published on 2019-12-09. 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

2021-05-21 · US FDA · 3 findings
Atlas Pharmaceuticals, LLC findings history — including this company's other documents US FDA documents, 2019 Go to Findings search