Validation and CAPA failures were among quality system failures uncovered during a Feb. 26 to March 1 FDA inspection of Pega Medical’s Quebec facility.
Process validation activities failed to include acceptance activities or documented evidence of manufacturing conditions representative of routine production activities, the five-item Form 483 said.
The heavily redacted 483 noted that no acceptance criteria were established and no product testing was conducted for a product as part of the validation exercises for the company’s pediatric orthopedic devices, including 3D-printed orthopedic implants.
CAPA procedures did not include an evaluation of the validation of related manufacturing processes after changes in respective manufacturing processes were implemented. The 483 notes that the impact of confirmed product failures was not evaluated as part of CAPA investigations.
Process control procedures were found to be lacking because they didn’t describe controls necessary to ensure conformance to specifications. For example, production and process controls don’t ensure that processing parameters were monitored or verified during routine production activities, the 483 said.
Finally, the FDA inspector found that changes in product inspection instruction plans were not documented or evaluated on related production change documents.
Read the Pega Medical Form 483 here: www.fdanews.com/09-20-18-pegamedicalinc483.pdf.