Finally, our products, after a month and half, are released from FDA hold (remember the FDA inspection and tips?). The world rejoices!!! or more like me myself and I rejoice!!!
Thanks team for the hard work, and thanks to our customers with patience, and thanks God for the blessing!
Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts
2011-03-02
2011-02-09
FDA inspection & tips
Wow! Finally.. It's been almost 3 weeks since the container arrived and everyday we are waiting for the FDA hold to be released but not getting status; now we are finally moving somewhere, and here's my tips
1. Have a great (good is not enough) relationship with your forwarder, and make sure their broker has an outstanding relationship with the FDA
- Why? Because they will be able to do something, trust me.
2. Make sure your shipper send you everything; literally E-V-E-R-Y-T-H-I-N-G that's ever needed (or not needed) for the documents; including but not limited to (* indicates important!)
- invoice*
- packing list*
- product ingredient*
- airway bills/ bill of lading
- photos of the products
- photos of the product packaging/ labels (if not yet available)
3. Follow up with your contact (whether it's forwarder, broker, FDA, and your customers) everyday to let them know you care and want to solve this issue together in a timely and professionally and politely manner
4. Know your products well, so when FDA calls you and ask you questions you are able to answer them in a soundly matter and seems legit.
5. Sit, Relax, and Pray. Once it's in the lands of FDA or USDA hold, there determines almost nothing you can do or know until FDA contacts you to either release the hold, or do physical inspection, or more. During this time there is absolutely no information provided such as what to expect or when to expect; so just live everyday as you would!
That's it, I hope this helps!
1. Have a great (good is not enough) relationship with your forwarder, and make sure their broker has an outstanding relationship with the FDA
- Why? Because they will be able to do something, trust me.
2. Make sure your shipper send you everything; literally E-V-E-R-Y-T-H-I-N-G that's ever needed (or not needed) for the documents; including but not limited to (* indicates important!)
- invoice*
- packing list*
- product ingredient*
- airway bills/ bill of lading
- photos of the products
- photos of the product packaging/ labels (if not yet available)
3. Follow up with your contact (whether it's forwarder, broker, FDA, and your customers) everyday to let them know you care and want to solve this issue together in a timely and professionally and politely manner
4. Know your products well, so when FDA calls you and ask you questions you are able to answer them in a soundly matter and seems legit.
5. Sit, Relax, and Pray. Once it's in the lands of FDA or USDA hold, there determines almost nothing you can do or know until FDA contacts you to either release the hold, or do physical inspection, or more. During this time there is absolutely no information provided such as what to expect or when to expect; so just live everyday as you would!
That's it, I hope this helps!
2010-12-02
FDA inspection
It was a surprise visit for the FDA inspection today and I am glad that here at ecoVegan we are well prepared and have our actions together.
If you are also in the food business and/or considering starting-up, here are a couple things I would recommend:
1. Get all the certifications/permits/license required in the very beginning. If you are not sure, a business plan is the best way to start because it will force you to look for the requirements (permits/license/certification) needed to operate a business. Tips: Score or SBA.
2. When dealing anything with food (either manufacturer, pack, repack, warehouse,etc), be sure to register for FDA. And trust me, they (and the State of CA Department of Public Health) will come and visit.
3. Always keep a log and record of what was done, whom you spoke to, and the conversation or the action. And have someone detail orientated to maintain the record.
4. Follow the rules/regulation/guidance/recommendation per the industry. Tips: FDA Guidance Documents.
5. Insurance, insurance, insurance! Even though it should have always been covered in the business plan, never forget insurance.
There are definitely more, but for now, after the FDA visits, that's all I can think about!
If you are also in the food business and/or considering starting-up, here are a couple things I would recommend:
1. Get all the certifications/permits/license required in the very beginning. If you are not sure, a business plan is the best way to start because it will force you to look for the requirements (permits/license/certification) needed to operate a business. Tips: Score or SBA.
2. When dealing anything with food (either manufacturer, pack, repack, warehouse,etc), be sure to register for FDA. And trust me, they (and the State of CA Department of Public Health) will come and visit.
3. Always keep a log and record of what was done, whom you spoke to, and the conversation or the action. And have someone detail orientated to maintain the record.
4. Follow the rules/regulation/guidance/recommendation per the industry. Tips: FDA Guidance Documents.
5. Insurance, insurance, insurance! Even though it should have always been covered in the business plan, never forget insurance.
There are definitely more, but for now, after the FDA visits, that's all I can think about!
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