In a recent inspection, FDA issued an observation that should unsettle any manufacturer relying on third-party warehousing: finished APIs and intermediates intended for the U.S. market were sent to an offsite warehouse that lacked documented receiving procedures, inspection records, environmental monitoring, excursion investigations, and segregation controls.
Under current FDA expectations, contractors, including third-party logistics providers and offsite warehouses, operate as extensions of the manufacturer’s quality system. Although portions of operations are often outsourced, cGMP responsibility cannot be outsourced.
According to the observation, the facility warehouse failed to provide:
- Incoming Receiving Procedures: No documentation of receipt dates, quantities, or supplier information.
- Incoming Inspection Records: No records of visual checks for drum integrity or signs of contamination.
- Storage Condition Monitoring: A lack of temperature and humidity records as specified for the APIs.
- Investigation Procedures: No protocol for handling environmental excursions.
- Segregation Records: No defined areas to separate quarantined, rejected, or returned goods.
Once a firm releases finished APIs and intermediates, its obligation to maintain its validated state does not pause during transport or storage. If the warehouse cannot demonstrate documented control over receipt, inspection, environmental conditions, and segregation, then the manufacturer cannot demonstrate that the product remained in compliance.
In this instance, a signed quality agreement often provides a false sense of security; however, FDA does not inspect contracts. FDA inspects systems. The question is not whether the agreement requires temperature monitoring. The critical question is whether temperature records exist, are reviewed, and are tied back to batch disposition decisions. If they do not, the gap belongs to the manufacturer.
This regulatory exposure extends beyond a single observation. When a warehouse is found to lack documented controls, the FDA may reasonably question the integrity of all product stored there. What begins as a warehousing lapse can evolve into broader questions about data integrity and quality oversight. Third-party storage does not dilute accountability. A 3PL’s lapse is the manufacturer’s lapse.
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