If you manufacture or distribute dietary supplements in the U.S., you are required to follow Current Good Manufacturing Practices (cGMPs). A key part of these rules is proper recordkeeping. But how long should you keep those records? And which ones matter most for FDA inspections or legal defense?
This guide breaks down the basic record retention rules for dietary supplement companies under 21 CFR Part 111, what documents you must keep, how long to keep them, and some best practices to avoid trouble.
Why Record Retention Matters
Good recordkeeping does more than check a compliance box. It helps you:
- Show FDA inspectors your operations follow GMPs
- Prove product safety and quality if there’s a complaint or recall
- Defend yourself legally if someone files a lawsuit
- Train employees and document internal changes
Records tell the story of how your product was made, tested, stored, and shipped. If they’re missing, incomplete, or outdated, it raises red flags.
Key FDA Retention Requirements (21 CFR Part 111)
According to the FDA, you must keep different types of records for at least 1 year past the product’s shelf life, or 2 years from the date the record was created, whichever is longer.
This applies to records such as:
- Batch production records
- Quality control records
- Ingredient and supplier records
- Equipment cleaning and calibration logs
- Packaging and labeling approvals
Let’s break this down further.
1. Batch Production Records (BPRs)
These show how each lot of a supplement was manufactured.
Keep for:
1 year past shelf life, or 2 years from record creation, whichever is longer.
BPRs must show:
- Formula used
- Ingredients added (lot numbers, weights)
- Dates and times of production
- Names of workers involved
- In-process checks
- Final disposition (released, rejected, reprocessed)
Why it matters: If a customer files a complaint about a specific lot, BPRs show what happened during production.
2. Product Specifications and Testing Records
This includes:
- Finished product specs
- Identity testing of raw materials
- Microbial and heavy metal testing
- Stability testing (if performed)
Keep for:
1 year past shelf life, or 2 years from test date.
Why it matters: These records help show that products met required specs at the time of release.
3. Supplier Qualification and Certificates of Analysis (COAs)
These include:
- Approved supplier lists
- COAs for raw materials
- Supplier audits
- Written procedures for qualification
Keep for:
2 years from the date created or received.
Why it matters: FDA inspectors may ask how you verified the identity and quality of ingredients. Having COAs is not enough, you must also verify them if they come from outside labs.
4. Packaging and Labeling Records
Includes:
- Label copies
- Label approval records
- Packaging inspection checks
- Tamper-evident seal documentation
Keep for:
1 year past shelf life, or 2 years from date created.
Why it matters: Accurate labeling is a legal requirement. Records show your labels had the right claims, ingredients, and warnings at the time of use.
5. Complaint Files and Adverse Event Reports
Includes:
- Written consumer complaints
- Internal complaint investigations
- Reports of serious adverse events (sent to FDA)
- Follow-up records
Keep for:
6 years (for serious adverse events per the Dietary Supplement and Nonprescription Drug Consumer Protection Act)
Why it matters: These records are often reviewed during inspections. They can also be requested during lawsuits or injury claims.
6. Standard Operating Procedures (SOPs)
You must keep:
- All written procedures used in your facility
- Any updates, changes, or revisions
- Employee training records linked to SOPs
Keep for:
2 years after they are no longer in use.
Why it matters: SOPs show that your team was trained to do things the right way. Outdated SOPs should still be archived for legal protection.
Best Practices for Record Retention
Following the minimum timeline is only part of the solution. Here are some tips to stay organized and audit-ready.
A. Use Digital Backups
Scan paper records or use digital systems with backup storage. Cloud storage with time-stamped logs is better than filing cabinets prone to fire, loss, or damage.
B. Track Expiration Dates
Use your ERP or inventory system to flag products by expiration date. This helps calculate how long to keep the related records.
Example:
If a supplement expires in Dec 2024, keep its batch and testing records until at least Dec 2025 (1 year after shelf life).
C. Label Your Files Clearly
Use consistent naming patterns:
- “BPR_Lot#1234_2023-06-10”
- “Label_Approved_VitaminC_2023”
- “COA_CalciumSupplierB_2024-01-15”
This makes it easier to retrieve specific files during audits or investigations.
D. Assign a Record Owner
Make someone responsible for maintaining, archiving, and destroying records when retention time ends. Use a calendar or software alert system to trigger reviews.
E. Don’t Rush to Destroy Records
Even if the official retention time has passed, keep records longer if:
- You suspect legal action may occur
- A product is still being investigated
- An ingredient is under regulatory review
It’s safer to wait than to destroy something that could defend you later.
What Happens If You Don’t Keep Records Long Enough?
If you throw away records too soon or can’t produce them during an FDA inspection, the agency may:
- Issue a Form 483 observation
- Mark you as non-compliant
- Delay product release or trigger recalls
- Recommend Warning Letters or import alerts
In legal cases, missing records weaken your defense. Courts may assume wrongdoing if you can’t provide documentation.
Summary Checklist: Key Records and How Long to Keep Them
| Record Type | Minimum Retention Time |
| Batch Production Records | 1 year past shelf life or 2 years (whichever longer) |
| Product Testing & Specs | Same as above |
| Supplier COAs & Qualification | 2 years from date created |
| Packaging & Labeling Records | 1 year past shelf life or 2 years |
| Complaint Files | 6 years |
| SOPs | 2 years after no longer used |
Conclusion
Staying on top of GMP record retention isn’t just about compliance, it’s about protecting your business. Follow the timelines set by 21 CFR Part 111, keep files organized, and plan your storage systems carefully.
The right record, at the right time, could save you thousands in fines or even help you win a legal case. Don’t treat documentation as an afterthought, it’s your shield in today’s regulated supplement industry.
