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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 The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
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