How should pharmaceutical product complaints be handled and investigated?

1What counts as a complaint.

For US drug manufacturers, the complaint procedure covers “all written and oral complaints regarding a drug product”.¹ ICH Q7 covers “all quality related complaints, whether received orally or in writing”.² For medical devices, ISO 13485:2016 defines a complaint as a “written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance” of a device released from the organisation’s control, or of a service that affects its performance.³

EU GMP Chapter 8 starts by sorting. Every complaint is documented and assessed to establish whether it represents a potential quality defect or another issue. Those that do not indicate a quality defect, such as suspected adverse events, are documented and passed to the people responsible for them, and special attention is given to whether a complaint relates to falsification.⁴

2What US drug CGMP requires.

21 CFR 211.198 sets the procedure and the record.¹

• Written procedures for handling complaints are established and followed.
• The quality control unit reviews any complaint involving the possible failure of a drug product to meet any of its specifications, and decides whether an investigation under 211.192 is needed.
• The complaint is reviewed to decide whether it is a serious and unexpected adverse drug experience that must be reported to FDA.
• A written record of each complaint is kept in a designated complaint file until at least one year after the product’s expiration date or one year after the complaint was received, whichever is longer.
• If an investigation is done, the record includes its findings and follow-up. If not, it includes the reason and the name of the person who decided.

An investigation under 211.192 “shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy”, with a written record of its conclusions and follow-up.⁵ Responsible officials not already involved are notified in writing of investigations under 211.198, and complaints are part of the annual review of each product.⁶

3What EU GMP Chapter 8 adds.

Chapter 8, in operation since 1 March 2015, applies quality risk management to the investigation and to decisions on recalls and other risk-reducing actions.⁴ The people managing complaint and quality defect investigations should be trained, experienced and independent of sales and marketing unless otherwise justified, and the Qualified Person who certified the batch is kept informed.⁴

A quality defect investigation procedure addresses at least the description and extent of the defect, the need for a sample or return, the risk it poses, the decision on risk-reducing actions such as a recall, the effect of a recall on supply, communications, the potential root cause and CAPA with its effectiveness.⁴ Other batches, and in some cases other products, are checked, previous reports are reviewed for recurring problems, and where human error is suspected it is formally justified.⁴

A quality defect that may result in a recall or an abnormal restriction in supply is reported in a timely manner to the marketing authorisation holder and all concerned competent authorities.⁴ EMA says that reporting does not wait for the investigation to finish, and that notification “should typically take place within one working day of confirmation that reporting is required”.⁷

4What the complaint record holds.

The drug record lists its items “where known”.¹ The API list is from ICH Q7.² The device list applies to complaints that must be reported under Part 803, complaints that must be investigated and complaints investigated anyway.⁸

5How the device rules differ.

Since 2 February 2026, 21 CFR 820 is the Quality Management System Regulation, which incorporates ISO 13485:2016 by reference.⁹ Part 820 adopts ISO 13485’s definitions, so its definition of a complaint applies.¹⁰ Complaint handling follows clause 8.2.2 of ISO 13485, and 820.35(a) adds records of the review, evaluation and investigation of any complaint involving the possible failure of a device, its labelling or packaging to meet its specifications. If a similar complaint has already been investigated, another investigation is not needed, but the justification is recorded.⁸ Complaints that meet the Part 803 criteria are reported to FDA.¹¹

Under Part 803, a manufacturer reports within 30 calendar days of becoming aware of information that reasonably suggests a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would be likely to do so if it recurred.¹² A 5-day report, due within 5 work days, is needed when an event requires remedial action to prevent an unreasonable risk of substantial harm to public health, or when FDA has asked in writing for one.¹³ FDA’s inspection programme for the QMSR lists complaint handling as one of the elements its investigators evaluate.¹⁴

6Trending and review.

Complaint records feed decisions beyond the single case. ICH Q7 asks for them to be retained to evaluate trends, product-related frequencies and severity.² EU GMP asks for quality defect records to be reviewed and trend analyses performed regularly,⁴ and US CGMP includes complaints in each product’s annual review.⁶ ICH Q10 lists complaints among the inputs to process performance and product quality monitoring and to management review.¹⁵

7How it runs in Seal.

Seal’s complaint workflow keeps the original report as received and gives each question in it, such as the technical investigation, the safety assessment and a request for the lot or serial number, its own record, owner and state, so finishing one does not close the others. A reportability assessment keeps the criteria applied, the facts known and missing, and the reviewer’s rationale. Once the product is identified, the complaint links to the batch record, the deviations on that batch, its release and where it was distributed, and a recall derives its scope from the genealogy.

Neil, Seal’s AI agent, can compare recurring complaints against lot history and distribution exposure to define a focused investigation. Complaint and quality owners assess significance and the reporting obligations.