FDA cited a firm for failures pertaining to labeling integrity, inspection, and storage.
The 483 observation reads:
“Specifically, your firm’s procedure, SOP …, ‘Labeling and Packing,’ has not been adequately defined because it continues to fail to ensure:
a. Label integrity. Labels shall be printed and applied to remain legible and affixed during the customary conditions of processing, storage, handling, and distribution.
b. Labeling inspection. Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the Device History Record (DHR).
c. Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mix-ups.”
Guidance from FDA under 21 CFR 211.125 and 21 CFR 820.120 requires manufacturers to control the issuance and storage of labels.
Even in otherwise compliant facilities, lapses in labeling SOPs can have outsized consequences. Misplaced labels can lead to dosing errors, incorrect patient use, and compromised traceability.
The common root causes we at GMP Trends repeatedly witness are:
- Inadequate SOP Definition: Procedures often describe what must be done but omit how to do it (no step-wise instructions for verifying expiration dates or UDI codes).
- Weak Documentation Practices: Failure to record label examination and release in the device history record leaves no compliance evidence.
- Storage Vulnerabilities: Labels or Instructions for Use that are stored in uncontrolled areas increase the risk of mix-ups or environmental damage.
- Insufficient Training & Oversight: Line staff may not understand UDI/UPC requirements or supervisors may overlook routine checks.
Labeling errors trigger costly recalls and reputational harm. The following is a non-exhaustive list of suggested action points for consideration by Quality Leaders:
- Re-evaluate Labeling SOPs: Make them procedure-driven, with explicit instructions for label inspection, reconciliation, and rejection criteria.
- Integrate Label Release into Device History Records: Ensure every inspection, approval, and signature is contemporaneously documented.
- Harden Label Storage Controls: Restrict access, maintain segregation, and monitor environmental conditions where appropriate.
- Refresh Training Regularly: Cover label integrity, reconciliation, UDI/UPC accuracy, and documentation discipline.
- Audit to Detect Drift: Periodically review labels in production and storage areas to confirm SOP adherence.
