Records Retention Period
We are preparing for PrimusGFS that specifies records at minimum of 1 year. Does the FDA require a longer records retention period? I really want to clear out some of the clutter. We are a very short shelf life product. 18 day max I believe. What type of records are you keeping longer than one year? Production records, quality checks, or just the verifications, test records, traceability? We are in Ohio. Thanks!
I. What Are the Record Retention Requirements? (Section 1.360)
40. General Questions 40.
1
Q: A facility receives a product with two-year record retention requirement, holds it for three years, and then releases it. Is the facility required to retain the incoming records until or some time after the product is released, regardless of the holding period?
A: The facility is not required to maintain any record for longer than two years after its creation at the time of the transaction it describes, because Section 306 of the Bioterrorism Act explicitly limits the retention of records to two years or less. Records created when a food subject to the two year record retention requirement is received may be discarded after two years, even if the product remains in the facility. The facility still must establish and maintain records identifying the transporter and nontransporter immediate subsequent recipient when the food is released in accordance with section 1.345, even if the retention period for the record identifying the immediate previous source has expired. If a facility anticipates that it may hold food for longer than two years, it may wish to retain records of receipt for more than two years as a matter of business practice. Such records could be helpful to both the facility and FDA in the event of a trace back or trace forward investigation.
Source: https://www.fda.gov/...n/UCM292795.pdf
I keep my records for the shelf life of the product+2 years, but that's because we have the space and I like to be able to look at past products sometimes as part of investigations.
Typical requirement is 2 years. Some special cases, such as high-acid canning, necessitate longer holding periods (I think 3 years).
If you deal with any organic then minimum if 5 years for all organic records. Since our facility handles organic and conventional we hold onto our records for 5 years minimum. Most of it is electronic so it is easier to keep longer.
Seafood seems to be different, slightly -
Question: How long must sanitation records be held if sanitation is not part of the HACCP plan?
Answer: 21 CFR 123.9(b) states that all records required by the regulation, including sanitation records, must be retained for one year for refrigerated products and two years for frozen, preserved or shelf stable products.
https://www.fda.gov/...m176892.htm#vii
But i anyway doubt that the Primus audit is intended for seafood ???? Fresh Produce in Ohio ???