Inspections, Compliance, Enforcement, and Criminal Investigations
Guide to Inspections of Medical Device Manufacturers
Verify the manufacturer has procedures to control labeling operations. The procedures should assure the following:
a. Labels are printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling distribution and where appropriate, use.
b. Labels are not released for storage or use until examined by a designated individual(s) for accuracy, including (where applicable):
1. correct expiration date
2. correct control number
3. storage instructions
4. handling instructions
5. any additional processing instructions
c. The release of labels is documented in the DHR by date of release and signature of person performing the examination.
d. Labels are stored in a manner that provides proper identification and is designed to prevent mixups.
e. Labeling and packaging operations are controlled to prevent labeling mixups.
f. The label and labeling used for each production unit, lot or batch is documented in the DHR.
g. Where a control number is required by 21 CFR 820.65, that control number is on or accompanies the device through distribution.
Verify the firm's packaging and shipping containers are designed and constructed to protect the device from alteration or damage during its customary conditions of processing, handling, storage and distribution. For devices labeled as sterile, this data will normally be found with the firm's sterilization validation data. Complaints and returns are places to look to see if the packaging and shipping containers do not provide this type of protection.
The firm should have written procedures in place that will ensure mixups, damage, deterioration, contamination or other adverse effects do not occur to product during handling and storage. Examples: ESD controls may be needed in areas where products with sensitive circuitry are packaged and stored. Segregated warehouse areas by physical or computerized means may be employed to prevent mixups relative to quarantined and released product or between similarly packaged products. Other warehouse practices should also be evaluated. Warehouse cleanliness is important for products with minimal packaging that are meant to be kept clean.
The procedures should assure no obsolete, rejected, or deteriorated product is used or distributed. There should also be procedures that describe how product will be authorized as received from and dispatched to storage areas and stock rooms. A review of distribution records cross-referenced to final inspection and release records and quarantine records should be done to verify obsolete, rejected, or deteriorated product has not been used or distributed. Records of receipt and dispatch should be reviewed to assure procedures are being followed.
When the quality of product is known to deteriorate over time, it must be stored in a manner that facilitates proper stock rotation. Its condition must be assessed as appropriate. Additionally, where a device's fitness for use or quality deteriorates over time, written procedures must ensure expired or deteriorated devices are not distributed. For raw materials or in-process materials, this may mean periodically performing incoming or in-process inspection and test. For finished devices with expiration dates, this may require the performance of shelf-life stability studies.
Written procedures are required to ensure only devices approved for release are distributed. The procedures must also ensure purchase orders are reviewed for ambiguities and errors and that any found are resolved before devices are released for distribution.
Distribution records are required and they must contain, or make reference to the location of:
a. Name and address of initial consignee
b. Identification and quantity of devices shipped
c. Date shipped
d. Any control number(s) used.
When devices require installation, there must be written procedures that describe the installation and inspection instructions, and where appropriate, test procedures. The installation instructions must be sufficient to ensure proper installation so that the device will perform as intended after installation. Service records can be reviewed to verify extra service calls are not required immediately after installation to make the device perform as intended. Installation instructions must be provided with the device or made available to the personnel responsible for installing the device.
The personnel installing the device must document the inspection and any test results that demonstrate proper installation. They are responsible for ensuring the device is properly installed, inspected and tested (when required) in accordance with the manufacturer's instructions and procedures.