1Laboratory and QC controls
The quality control department was not a distinct unit that functioned independently and reported to management independent of any other unit.
Inspection Record
Sciences de la Peau Crescita Inc. / Crescita Skin Sciences Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The ongoing stability program for a drug was inadequate.
3Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
4Complaint and recall handling
The written procedures for recalls were inadequate. The written recall system did not include distribution records that allowed each drug to be traced.
5Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Material and supplier control
The protection of products and/or materials from contamination was inadequate.
8Quality unit oversight
The annual product quality review procedure was inadequate.
9Material and supplier control
Operations on different products were carried out simultaneously or consecutively in the same room. The handling of rejected materials and products was inadequate.
10Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
11Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
12Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
13Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
14Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate. The master formulas to control the manufacturing process were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
15Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-02-12. 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.
