820.140 Handling.

Each manufacturer shall establish and maintain procedures to ensure that mixups, damage, deterioration, contamination, or other adverse effects to product do not occur during handling.

Sec. 820.150 Storage.

(a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.

(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.

Interpretation:

Storage should always be done under systematic, orderly conditions (820.150). Manufacturers should use a first-in, first-out (FIFO) distribution system when fitness for use of a device deteriorates over time (820.150).

When a controlled environment is necessary to prevent abnormal deterioration, the environment should be specified, controlled, and monitored according to sections 820.70(c) (see Chapter 6, Buildings and Environment). Environmental specifications, such as storage temperature, should be included in the device master record.

The storage and handling of devices to be distributed may involve extensive activities (820.140 and 820.150). For example, damaged, recalled or returned devices should be suitably marked and segregated from devices acceptable for release (820.86). Returned devices should be handled and stored such that the cause of failure or other useful information is not destroyed. Returned defective devices should be formally investigated according to 820.100 Corrective and Preventive Action and any associated complaints investigated according to 820.198. Therefore, manufacturers will need controls to assure that returned defective devices do not dead-end in the warehouse, but are expeditiously routed to the appropriate department for evaluation, investigation, conclusions and follow-up (see Chapter 15, Complaint Files).

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Reference: www.FDA.gov

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