Labeling & Packaging Procedure required by the state of California

S

Slaterson22

#1
I recently was inspected by the state of California, and was cited for not having established labeling procedures for my packaging. I am looking to purchase a labeling procedure and I can't seem to find one.

I've looked on the FDA website and I have seen what the requirements are, but I don't feel comfortable writing my own procedure. Does anyone have a general small business 13485 procedure for labeling and packaging? Any help would be appreciated!!

Thanks,
Doug in California
 
Elsmar Forum Sponsor
Q

QAMTY

#2
Re: Labeling & Packaging procedure

HI

Go to
"Post attachment list" and and "More free files" on top
of the main Menu.

You´ll find samples of procedures.

Hope it can be useful for you
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
Re: Labeling & Packaging procedure

I doubt we have anything here specific to the state of California. Am I wrong in guessing the procedure is a requirement by the state of California but there are no "qualifications" of what the procedure must contain and that any Labeling & Packaging Procedure will do?

I'm wondering where this requirement came from, and whether it is a specific requirement for a *documented* procedure. Is this a requirement of ISO 13485 (I don't have a copy of it)?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I recently was inspected by the state of California, and was cited for not having established labeling procedures for my packaging. I am looking to purchase a labeling procedure and I can't seem to find one.

I've looked on the FDA website and I have seen what the requirements are, but I don't feel comfortable writing my own procedure. Does anyone have a general small business 13485 procedure for labeling and packaging? Any help would be appreciated!!

Thanks,
Doug in California
Hi Doug,

In order to get (or create) a procedure that would satisfy the state's requirements, it's highly important to first know and understand the explicit requirement-establishing (legislative) text. Personally, I don't master the state of CA specific medical device related legislation / regulation; I hope you'll be lucky enough to have someone with such expertise around here :) As a starting point, do you have a more specific pointer (or can you get one from your inspector) to the legal document, and preferably the exact section, that establishes the requirement against which you were cite? ("Show me the shall...") Does the requirement directly relate to ISO 13485, in a way?...

Cheers,
Ronen.
 
Last edited:

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: Labeling & Packaging procedure

I doubt we have anything here specific to the state of California. Am I wrong in guessing the procedure is a requirement by the state of California but there are no "qualifications" of what the procedure must contain and that any Labeling & Packaging Procedure will do?

I'm wondering where this requirement came from, and whether it is a specific requirement for a *documented* procedure. Is this a requirement of ISO 13485 (I don't have a copy of it)?
ISO 13485:2003's take on labeling operations is quite limited:

S. 7.5.1.1:

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable
(...)
g) the implementation of defined operations for labelling and packaging.
(...)
Please note "defined operations" vs. "documented procedures". Hopefully some expert-auditor Covers will comment on this subtle difference :)
 
Thread starter Similar threads Forum Replies Date
C Packaging & Labeling Standard Operation Procedure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
J Biologic Injectable Device Clinical Trial Packaging/Labeling/Artwork Guidelines Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
shimonv Over-Labeling Sterile Packaging - Shelf Life 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
J GUDID Labeling and Levels of Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M GUDID/UDI Packaging and Labeling Questions Other US Medical Device Regulations 6
S Three Questions on Finished Medical Device Traceability, Labeling and Packaging US Food and Drug Administration (FDA) 3
C Hazardous Good Packaging Labeling for Airfreight EU EASA and JAA Aviation Standards and Requirements 2
J SFDA Finalizes its Rules on Packaging and Labeling of Imported Medical Devices China Medical Device Regulations 0
R HACCP for Packaging, Labeling and Warehouse of Food Products Food Safety - ISO 22000, HACCP (21 CFR 120) 13
J Labeling Software for Medical Device Product and Packaging Labels for Production Use Other Medical Device Regulations World-Wide 5
C Class I Medical Devices - Country of Origin Marking on Retail Packaging (Labeling) Other US Medical Device Regulations 4
I Drug Products - Packaging and Labeling Operations Requirements - 211.130 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
J Labeling Requirements all levels of Packaging EU Medical Device Regulations 5
N Re-Packaging and Re-Labeling Bulk Lots of Class II Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C QSR 820.120 labeling and packaging control 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N CE Marking MDD & EN 980 Labeling Requirements, IFU, Packaging, etc. EU Medical Device Regulations 6
H CE Language Requirements on labeling (both device and packaging) ISO 13485:2016 - Medical Device Quality Management Systems 27
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E Annotated US Prescribing Labeling US Food and Drug Administration (FDA) 0
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom