FDA Inspection, Sharing Important Pointers

Finally, the FDA inspector arrived in coffee shop. We were a bit prepared as he called late in the day prior to visit. The staff had given very little time to prepare. Clean all equipment, tools and facilities. It was very short, but at least, not a horrible suprise visit which was what we expected. I also managed to arrive at site, heared his comments and tend to his needs.

To make the long story short, the application was not approved. Not yet until we comply to all his recommendations that should accomplish within a specified time frame. Else, application will be considered void. A repeat from the start.

I will not list all comments. It is an eye popping wall of text when written. Instead I am sharing important pointers that might help with your own establishment.

1) The process starts from ” dirtiest to cleanest”. There are only two plant design to be considered. The first is straight line and the second is “L” shape.

2) No to old fragile incandescent bulb, CFL bulb, flouresence lamp, and new LED bulb. If they are to be used, they should be enclosed in protective cover. He recommended the new polycarbonate LED bulb as good alternative.

3) Implement lot numbering for traceability.

4) Prepare a product recall procedure.

5) Always keep a reference sample. It is very important in case the situation goes out of hand. I did a rough estimate and it gonna result to lots of sales lost. Something should be done to compensate for this.

6) Proper record keeping and filing. This guy asks a lot of thing. You better be prepared.

8) Only things that are needed in specific production area should exist. Everything in excess are considered source of contaminant.

9) Observed proper hygiene. We hear it everytime and yet we often fail.

10) Build those comfort room outside the production area.

11) Consider conducting a regular internal and external audit.

There are still lot more to say but I guess that’s all the most important. Hope it helps.

FDA License Application | Afater 4 months

How long has it been since I filed the license to operate application of that coffee manufacturer? It’s been four months already. The customer service representative who accepted the application papers clearly stated it usually takes ten working days. However, it still depends on availability of inspectors. I never thought their inspectors are so few that it is taking them so long to do their jobs.

This is not an isolated case. Most of my friends have the same sentiments. They needed the “license to operate” badly but they can’t do anything but wait.

Why is it always like this? Government offices are allowed to commit delays but their clients are not. I renewed my drivers license six months ago but my license is still temporary paper. Late vehicle registration have corresponding penalties but they don’t have to worry about the late release. Take BIR for example. I am paying huge amount due to my negligence. They are collecting large taxes from workers and employers but never bother improving the TIN ID.

A friend of mine have nice suggestions on FDA matter. They know very well they lack employees, so why not hire more? Why not file a law, order or rules that when a food establishement who filed application on time never inspected within the specified time limit, they will automatically get the license approved.

What I have in mind is different. Food establishement licensing could be transferred to local health centers. They have narrow scope and could visit manufacturers on random or even regular basis.

In the end, I could do anything but wait.

Public Health Warning on Aro Baro Guyabano Health Products

March 15, 2013, FDA Philippines issued an advisory warning the public about the, “Aro Baro Churo Organic Tea, Aro Guyabano Tea and Aro Baro Churo Guyabano Capsules”. They are unregistered products claiming to be 10,000 times stronger than chemotherapy and have Adriamycin as active ingredient.

The public is hereby warned not to buy the said products and others which are not registered. They are expensive, ineffective and may cause adverse reactions that can be life threatening.

Adriamycin is a trade name for Doxorubicin. It is an anti-cancer chemotherapy drug. It is administered intravenously but may also be given in infusion. It has the following possible side effects.

Pain due to injection needles and after affects of injection process
Nausea and vomiting
Low blood counts
Mouth sores
Hair loss

less common side effects are:

watery eyes
urine discoloration, red, red-brown, orange or pink
nail beds darkening
skin darkening
fertility problems

source / chemocare.com
source / fda.gov.ph
original advisory file….