Inspection Record

Haemotec, a division of Fresenius Medical Care Canada Inc. — Health Canada Inspection Findings

Health CanadaInspected 2021-02-16 4 findingsLabeling and packagingCleaning validationMaterial and supplier control

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

Findings

1Labeling and packaging

The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).

2Cleaning validation

The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.

3Material and supplier control

The sampling plan for raw materials was inadequate.

4Material and supplier control

The standard operating procedures or records for shipping and receiving raw materials were inadequate.

About this record

Extracted automatically from the document of the Health Canada inspection on 2021-02-16. 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.

Haemotec, a division of Fresenius Medical Care Canada Inc. company profile — full history Health Canada documents, 2021 Go to Findings search