Hi All,

We just finished both our ISO certification and FDA audits in the same week (talk about stressed out). We had one observation for improvement from the ISO audit and one finding from the FDA surveillance audit...I could have done in without all the good info people on the forum have shared..thanks! :thanx:

Anyways, I am a little be-fuddled by the one FDA finding. We were cited for our procedure on traceability not being adequate. Specifically, the auditor said that the procedure needed to include a description on how to interpret our lot numbers. Our lot numbers are pretty much sequential so I am not such what people should be "interpreting." I did ask the auditor at the closing meeting which CFR we had violated and she couldn't tell me...any ideas?

Overall our traceability system is rock solid with software that generates and traces our lot codes. But I was wondering if anyone else had this type of finding...or could explain it a little better :bonk:

thanks in advance for your help

Hi All,

We just finished both our ISO certification and FDA audits in the same week (talk about stressed out). We had one observation for improvement from the ISO audit and one finding from the FDA surveillance audit...I could have done in without all the good info people on the forum have shared..thanks! :thanx:

Anyways, I am a little be-fuddled by the one FDA finding. We were cited for our procedure on traceability not being adequate. Specifically, the auditor said that the procedure needed to include a description on how to interpret our lot numbers. Our lot numbers are pretty much sequential so I am not such what people should be "interpreting." I did ask the auditor at the closing meeting which CFR we had violated and she couldn't tell me...any ideas?

Overall our traceability system is rock solid with software that generates and traces our lot codes. But I was wondering if anyone else had this type of finding...or could explain it a little better :bonk:

thanks in advance for your help

Hi and welcome to the Cove! :bigwave: Congratulations on your certification audit! :agree1:

Maybe what the FDA investigator was looking for is some way that the lot numbers are tied to a date or time period. For example, our lot numbers include the year, julian date of manufacture, production line/machine, and in some cases even the inspector who packed the product.

However, if you can prove that traceability is rock solid and you're able to trace forward and backward, I don't know why this would be an issue. As for your procedure on traceability, perhaps just a simple statement that lot numbers are assigned sequentially and tracked by the software might be sufficient...?

It's strange that the investigator either was not able to cite the CFR section violated or chose not to...:confused:

When an auditor says somethings 'inadequate' it's a biased finding. Without evidence of why it's inadequate, they are simply giving you their personal bias.

Could she find examples of duplication of lots, errors in printing, transposition of numbers etc? If not, she's trying to exercise her will on you to change it, without anything other than 'feelings'.

I can look at something and say it's inadequate, but without some reference to what's 'adequate' how do you know what to fix?

Specifically, the auditor said that the procedure needed to include a description on how to interpret our lot numbers. Our lot numbers are pretty much sequential

You've answered your own question. Just state in your procedure that lot numbers are assigned sequentially.

In my experience, it's not worth arguing with the FDA over little stuff like this.

Just state in your procedure that lot numbers are assigned sequentially.


It's always good to define the lot number convention and then provide an example.

Convention--> XXYY-0000,
where XX is the factory identifier, YY is the year, and 0000 is the sequential number of the lot produced.

Example: The 53rd lot produced in 2008 at the Elsmar Cove facility would have a lot number EC08-0053.

Factory identifiers:
Elsmar Cove -- EC
Nevernever Land -- NN
Metropolis -- MT

I think I definitely have an idea on how to revise the procedure...thanks everyone;)

In addition to excellent responses so far, some additional "Food for Thought"

1. Ensure your procedure covers all steps to ensure that traceability works as the material moves through different sections.

2. If you are alloting lot nos for semi finished stages, mention the numbering system in procedure (For eg. aa-bb-yy-001 - where aa stands for Customer Name, bb stands for Dept, yy stands for year followed by sequential digits). Also mention that customer name shall be the first 2 alphabets; Dept name will be MO for moldihng, PA for painting, AS for assemnbly etc, year to be represented by 08 for current year and sequnetial numbering to start from 001.

3. In your Internal Audit checklist, ensure that backward and forward traceability is always checked as an example.

Hope that helps.

Hi Knight
I would agree with Scott.
There is no need to revise your lot numbering process to a more complicated one, but I would suggest that you must revise your procedure SOP for lot numbering and clearly mention how lot numbers are assigned sequentially.
I wont mention the name of the company, but even a big multinational company is unsing only 4 digit lot number.
Its very rare finding. No need to worry about. FDA has to justify their jobs.

As an ex FDA investigator, I am probably guessing that there was no written procedure pertaining to the lot number scheme. If the scheme is sequential, then just say so in a procedure. Remember, not only do 820.60 & 820.65 (identification & traceability) apply, but also 820.184 (DHR's) applies too regarding lot/control numbers.

As a side note- When FDA collects attachment B recall information, the written procedure re the lot number scheme is collected to aid district recall coordinators.