Deviation & Failure Case Studies – Page 13

Incorrect artwork version used during inspection – recall risk case study

In the lead-up to a critical FDA inspection, quality control (QC) personnel noticed discrepancies during the final packaging checks. These discrepancies included the following:Click to read the full article.

Packaging deviation repeated during deviation review – regulatory reporting outcome

During routine batch processing, multiple discrepancies related to labeling accuracy were reported in the packaging department. Notably, the same labeling error appeared in several sequential batches, leading to a heightened…

Tamper seal deviation during artwork change – CAPA ineffectiveness analysis

In early November 2023, Quality Assurance (QA) personnel observed discrepancies in tamper seals on the packaging line while conducting routine quality checks of newly printed artwork. The observed symptoms included:Click…

Packaging deviation repeated during deviation review – CAPA ineffectiveness analysis

During routine quality assurance audits, the Quality Control (QC) team discovered multiple packaging deviations in the same product line over a span of three consecutive months. Key symptoms included:Click to…

Line clearance failure causing mix-up during deviation review – CAPA ineffectiveness analysis

The initial indicators of the issue consisted of several discrepancies reported during the batch review process. Operators noted:Click to read the full article.

Label reconciliation failure during packaging operations – recall risk case study

During routine operations, quality control personnel noted irregularities in the packaging lines, characterized by an unexpected spike in batch rejection rates. Symptoms included:Click to read the full article.

Tamper seal deviation during artwork change – recall risk case study

The initial detection of the tamper seal deviation occurred during a routine quality audit, where it was noted that some product units lacked the required tamper evident seals. Further inspection…

Tamper seal deviation during deviation review – regulatory reporting outcome

The incident began when a quality control inspector noticed inconsistencies in the tamper-evident seals on a batch of finished drug product packaging. Specifically, the seals did not match the approved…

Tamper seal deviation during packaging operations – regulatory reporting outcome

The occurrence of a tamper seal deviation may present itself through several observable symptoms on the production floor. In our case study, employees noticed the following signals during a routine…

Serialization mismatch detected during artwork change – recall risk case study

During a routine quality control (QC) check, analysts identified discrepancies in the serialized numbers on packaging materials after an artwork update. The labels produced reflected incorrect serialization data that did…

Label reconciliation failure during inspection – recall risk case study

During a routine inspection of a finished goods warehouse in a pharmaceutical manufacturing facility, quality assurance (QA) personnel identified discrepancies in the label reconciliation process for a recently packaged batch…

Cleaning SOP deviation ignored during equipment changeover – cross-contamination risk case study

The scenario began with an alarming increase in out-of-specification (OOS) results recorded during post-manufacturing quality checks for a specific product batch following equipment changeovers. Operators reported unusual residue found on…