1Laboratory and QC controls
The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch.
Inspection Record
A & C American Chemicals Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The quality control department's documentation, labelling, and/or quarantining of raw materials, packaging materials, in-process drugs, and/or bulk drugs was inadequate.
3Material and supplier control
Lots and/or batches of packaging materials were not examined and/or tested against the written specifications before they were used.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Complaint and recall handling
The written procedures for recalls were inadequate.
6Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
7Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
8Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Material and supplier control
The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-07. 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.
