Sterile Barrier Packaging Manufacturer Gets FDA Warning
GS Medical Packaging Inc. is a manufacturer of sterile barrier packaging. Following an inspection in January 2013, the FDA issued the company with a warning letter in June. This may not be the first warning letter to a packaging manufacturer, but it is the first I have come across.
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example: No procedures for design control have been established to govern new medical device designs or changes to existing designs...
2. Failure to establish and maintain procedures that ensure that complaints are evaluated to determine whether the complaints represent an event that is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
For example: Your firm does not have established procedures to ensure that complaints are evaluated for events that are reportable under the medical device reporting regulations, and no such evaluation is documented in individual complaint records...
3. Failure to establish and maintain procedures for acceptance activities, including inspections, tests, or other verification activities, as required by 21 CFR 820.80(a).
For example: Your firm does not have procedures for conducting the (b)(4)* Test on finished product lots, including, how sampling is conducted; the number of samples per lot; test parameters and methods; acceptance criteria; procedures for when failing results are obtained; and documentation of test results...
4. Failure to maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of this part, as required by 21 CFR 820.184.
For example: Your firm does not have written procedures that govern which documents and information should be present in each DHR. Also, DHRs do not contain a final release signature of the person authorized to release each lot for distribution...
It is unfortunate for such a well established company to have its failings publicized in this way. I guess this will serve as a wakeup call to other packaging producers for the healthcare industry. Not all packaging manufacturers will realize that they may be subject to FDA scrutiny. MDMs should also be alerted to ensure that they regularly audit their packaging vendors.
* This test detail is redacted in the FDA letter.
Rolande Hall, FIMMM Pkg Prof