Quality, Complaint & Recall SOP

Version 2026.05.22. Even though products are RUO, a disciplined complaint and recall process protects researchers and the business. Keep a signed copy on-site.

1. Incoming quality gate

• No lot becomes pickable until its COA is on file and matches spec (≥ stated purity, identity confirmed, endotoxin within limit).
• Out-of-spec lots are quarantined and returned to the supplier or destroyed; recorded in the audit log.

2. Complaint intake

A complaint is any report that a lot is off-spec, contaminated, mislabeled, broken, or otherwise deficient. Channels: support ticket, RMA portal, email, phone.

• Log every complaint with date, lot, SKU, customer, and description.
• Acknowledge to the customer within one business day.
• Classify severity: (1) cosmetic/packaging, (2) potential quality deviation, (3) potential safety/identity issue.

3. Investigation

• Pull the lot's COA, the retained label proof, the PO, and the storage/temperature record.
• If the complaint indicates a true deviation, place an immediate hold: admin Inventory → Mark OOS for the lot's SKU, and pull the lot from any pending picks.
• Determine scope: single vial vs. whole lot. Check how many units of the lot shipped and to whom (admin order records carry the picked lot).

4. Recall decision

A recall is warranted when a lot is mislabeled, off-identity, contaminated, or otherwise unsafe to continue distributing.

• Owner or Manager authorizes the recall (logged).
• Classify: Class I (reasonable probability of serious harm), Class II (temporary/reversible), Class III (unlikely harm) — using FDA's framework as a discipline even for RUO.

5. Recall execution

1. Stop sale immediately (Mark OOS, remove from catalog if needed).
2. Identify every customer who received the lot (filter orders by picked lot).
3. Notify each affected customer by email with the lot, the issue, and the remedy (replacement or refund), via the ESP. Log each notification.
4. Update the public COA library entry with a recall flag.
5. Offer return shipping and process replacement/refund through the RMA + Refunds tabs.
6. Post a notice on the home-page banner if the recall is Class I or II.
7. Notify the supplier and, where legally required, the relevant authority.

6. Root cause & CAPA

• Document the root cause (supplier, storage, labeling, handling).
• Corrective action (fix the immediate issue) and preventive action (stop recurrence).
• Update the relevant SOP and re-train.

7. Adverse event note

We do not authorize human use, so we do not collect human adverse-event data. If a report nonetheless arrives describing human exposure, we (a) do not provide medical advice, (b) direct the person to Poison Control (1-800-222-1222 in the US) or emergency services, and (c) log the report for the file. We do not delete such reports.

8. Records & retention

Every complaint, investigation, recall, notification, and CAPA is retained for 7 years in the audit-backed file.

9. Mock recall

Run a mock recall annually: pick a random recent lot and trace it end-to-end (supplier → bin → every customer) within 4 hours. Record the time-to-trace.