This document discusses product complaints and recalls. It defines a complaint as any expression of dissatisfaction with a product. Complaints can come internally from production or quality control or externally from customers. Complaints are classified as critical, major, or minor depending on their severity and health risks. The document outlines guidelines for designating a person to handle complaints, investigating complaints, providing corrective actions and feedback, and analyzing complaint trends. It also defines and discusses the types and procedures for product recalls when serious quality issues are found.

1. BY: KIRANKUMAR SOLANKI
MARKET COMPLAINTS
&
PRODUCT RECALL

2. INTRODUCTION
 What is a complaint?
 A complaint is any expression of dissatisfaction with
a marketed product or service.
 FDA Definition:
 Complaint means any written, electronic, or oral
communication that alleges deficiencies related to the
identity, quality, durability, reliability, safety,
effectiveness, or performance of a device/product
after it is released for distribution.

3. Complaints: Principle
 “All complaints and other information
concerning potentially defective products
must be carefully reviewed according to
written procedures and corrective action
should be taken.”

4. Sources of complaint
 Internal and External
 Internal : complaint
can be from Production,
Quality Control,
Warehouse and
Marketing Division
 External : complaint
can be from customers,
doctors, paramedics,
clinics, hospitals,
pharmacy’s, drugstores,
supermarkets and NRA.
 Verbal and Written
 Verbal : complaints
received by oral and
must be documented by
appointed person.
 Written : complaints
received in writing (e.g.:
mail, letter, etc).

5. Classification of Complaints/Defects
 The following system has been found in some
countries for Classification of Defects (but it is
not a WHO/FDA guideline):
Critical defects
Major defects
Minor defects

6. Classification of Complaints/Defects
 Critical defects
 Complaints related to defective/ dangerous/
Potentially life-threatening medicines that
predictably or probably could result in to serious
health Risk /adverse events or even death.
 For Example (But not limited to):
 Wrong Product (Label and contents are different).
 Correct product but wrong strength, with serious
medical consequences.
 Wrong active ingredient in a multi-component
product, Mix-ups of some products.

7. Classification of Complaints/Defects
 Major defects
 Complaints that could cause illness or mistreatment,
but are not critical.
 For example (but not limited to):
 Mislabeling (Wrong or missing text or figures)
 Missing or incorrect information (leaflets or inserts)
 Chemical /Physical contamination
 Non-Compliance with specification

8. Classification of Complaints/Defects
 Minor defects
 Complaint which may not pose a significant hazard
to health.
 Complaints due to secondary packing materials,
Shortage complaints, Damage of containers.

9. WHO GUIDELINE FOR COMPLAINT
 There should be a designated responsible
person:
To handle complaint
To decide the measure to be taken
He may be authorized person - if not, must
advise authorized person of results
Sufficient support staff
Access to records

10. WHO GUIDELINE FOR COMPLAINT
 There should be written procedure (SOPs) describing
action to be taken including need to consider a
recall.
 Any complaint concerning a product defect should be
recorded with all the original details and thoroughly
investigated.
 The person responsible for quality control should be
involved in the study of such problems.

11. WHO GUIDELINE FOR COMPLAINT
 If a product defect is discovered or suspected in a batch,
consideration should be given to whether other batches
should be checked in order to determine whether they
are also affected.
 All the decision and measures taken as a result of a
complaint should be recorded and referenced to the
corresponding batch records.

12. WHO GUIDELINE FOR COMPLAINT
 Complaint records should be regularly reviewed for any
indication of specific or recurring problems that require
attention and might justify the recall of marketed
products.
 The competent authorities should be informed if a
manufacturer is considering action following possibly
faulty manufacture, product deterioration, or any other
serious quality problem with a product.

13. HANDLING OF COMPLAINTS
 It involve 4 steps:
 Step 1: Receiving Complaints
 Step 2: Technical Investigation
 Step 3: Corrective Actions and Feedback
to Customers
 Step 4: Monthly Reports and Trend
Analysis

14. Step 1: Receiving Complaints
 It is important to have open channels with customers
in order to receive their suggestions, doubts and
complaints.
 Generally, these channels are toll-free numbers, e-
mails, chat-rooms and P.O. boxes.
 Whatever the channel, it is necessary to have a
person in charge of receiving the complaints and in
putting them into an appropriate investigation form
that shall be addressed to the Quality Assurance
(QA) unit for investigation.

15. Data required for investigation of
complaint
1. Nature of complaint
2. Returned complaint sample
3. Detail examination of returned sample
4. Detail examination of kept(retained) sample
5. Consultation with relevant production and QA staff
6. Analysis of complaint and keep samples if
necessary
7. Cross Correlation with previous complaint
8. Examination of manufacturing and packaging
record
9. Product name and batch number
10. Name and address of complainant

16. Step 2: Technical Investigation
 Upon receipt of the investigation form, the QA unit is
able to start the investigation, which can be divided in
two phases:
 Documentation based investigation
 Checking if this complaint occurred previously in the
same lot or if any nonconformance was found in the lot
during its production.
 Laboratory analysis phase
 Requesting QC laboratory to analyze both samples
(complaint & retained).
 If the customer did not send the complaint sample
investigation will be carried out only with the retained
samples.

17. Step 2: Technical Investigation
 After receiving the analytical results, there are three
possible conclusions, as follows:
1. Confirmed complaint - When both complaint and
retained samples showed out-of-specification (OOS)
results or when only the complaint sample showed OOS
results, it is clearly a single unexplained failing product.
 Example:
 a single unexplained failure may be when one tablet is
missing in the intact blister strip in the complaint
sample, but no deviation was found in the retained
samples or during the in-process controls and final QC
analysis recorded in the batch record.

18. Step 2: Technical Investigation
2. Non-confirmed complaint - When both
complaint and retained samples showed results in
compliance with specifications or when only the
complaint sample showed OOS results that cannot
be considered a single unexplained failing product.
 OOS results in a complaint sample can be attributed
to misuse or mishandling.
 Example:
 Tablets of the complaint sample show a change in
their appearance that is characteristic of a light,
humidity or high temperature exposure.

19. Step 2: Technical Investigation
3. Counterfeit / tamper suspicion - When the
retained sample is within the specification but the
complaint sample is clearly OOS with no reason for
that, such as a counterfeit or tampered drug product.
 Example:
 when packaging material is different from the
original; an example of tampering is when the color
of the drug product is completely different from the
original or when any foreign substance was added to
the product.

20. Step 3: Corrective Actions and Feedback to
Customers
 Corrective actions can range from a simple and quick
training to some employees to a formal Corrective
Action and Preventive Action (CAPA)
handling.
 The criteria for choosing appropriate action depend
on the nature of the complaint, and the complaint
incidence.
 If a CAPA is opened, a multidisciplinary team
consisting of representatives of QA, QC, Regulatory
Affairs and Production management must be
established.

21. Step 3: Corrective Actions and Feedback to
Customers
 As feedback to the customer, the company must
write a response letter to the complainant to explain
the investigation approach taken, the results
obtained and any implications, in case the quality
problem was confirmed.
 The customer should be sent a free replacement
product together with the response letter, since the
customer returned the product (the “complaint
sample”) to the company for analysis and a quality
problem was found.

22. Step 3: Corrective Actions and Feedback to
Customers
 Concerning non-confirmed complaints originating
from misuse or inadequate handling of the drug
product, even if there is no need for internal
corrective actions, corrective measures should be
implemented to provide orientation to the customer.

23. Step 4: Monthly Reports and Trend Analysis
 Monthly reports should be elaborated in order to
evaluate the amount and the nature of the
complaints received and to perform a trend analysis
of these complaints.
 The monthly reports must answer the following
questions:
 How many complaints did the company receive in
the period?
 How many were confirmed?
 How many were non-confirmed or were
counterfeit/tamper suspicion?

24. Importance of handling complaints and
recall appropriately
 Identifying and addressing the root cause of
complaints will help to prevent the recurring of
complaints.
 Reviewing trends of complaints can help to tackle
systemic issues before it got worse.
 A decreasing trend of complaints also shows
customer satisfaction or trust in the product/service.
 Appropriately handled complaints can help to retain
or get more customers and ensure customer
satisfaction.
 If there are serious quality problems and there are
potential harm to consumer, product recall shall be
considered.

25. Documentation
1. Contents of the complaint
 Name, dosage form, package type, batch no.;
 Date and place of the occurrence of the
complaint;
 Causes of complain;
 Name and address of the complainant in detail.

26. Documentation
2. Results of investigations
 These should include:
 Result of investigation regarding market place,
circulation condition and condition in which the
defect was obtained;
 Result of investigation of retained reference
sample;
 Results of investigation of analysis and testing
records, production and storage records
 Results of investigation should be referenced to
the BPR of the product.

27. Documentation
3. Evaluation:
 Signature of evaluator with date.
4. Follow up measures :
 Reply to the complaint.
 Remedial action so that the complaint of this type do
not recur and or drug recall.
 Competent authorities should be informed of any
serious defect of problem.

28. Product Recall
 Definition :
 Removal of specified batches of a product from the
market, it may refer to one batch or all batches of
product.
 Principle:
 “There should be a system to recall the product from
the market promptly and effectively for the products
known or suspected to be defective.”
 Recall is a fast and effective method of removing
distributed product from the market, particularly when
many lots of product have been widely distributed.

29. Types of product recall (General)
1. Voluntary recall (Firm initiated recall):
a. Customer complaint.
b. Manufacturer himself finds out a defect in the
product and may decide to recall the product.
2. Mandatory recall (FDA/other authority
requested):
 Directed by the national regulatory authorities.
 Regulatory official find that a sample drawn by them
from market and analyzed by the government
analysts lab shows the product to be substandard and
ask the manufacturer to recall the product.

30. Types of product recall
(On basis of severity of health hazard)
 Class I (FDA requested recall), defined as a
situation in which there is a reasonable probability
that the use of, or exposure to, a violative product
will cause serious adverse health consequences to
death;
 Class II ( firm initiated recall), defined as a
situation in which use of, or exposure to, a violative
product will cause temporary or medically
reversible adverse health consequences or where
the probability of serious adverse health
consequences is remote;

31. Types of product recall
(On basis of severity of health hazard)
 Class III (firm initiated recall), defined as a
situation in which use of, or exposure to, a violative
product is not likely to cause adverse health
consequences.

32. Reasons for product recall
 Detection of quality and safety failure after
release.
 Result from the ongoing stability testing.
 Result of an inspection- label mix up, low volume,
leaking of product etc.
 Sometime stocks at various depots, etc. are
affected by natural calamities like flood etc. and
get damaged. When this information comes,
manufacturer recalls the product or asks to return
the product.

33. Reasons for product recall
 Tampering- At time during the transportation of
goods some accidents may take place and the
products get damaged, hence such damaged
product are recalled by the manufacturer for
evaluation and possible salvaging.
 Sometimes products are tampered willfully by
some persons or product gets tampered due to
mishandling.

34. Recall Procedure
 Responsibility:
1. The general manager (the highest person in managements)
has the ultimate responsibility to direct the prompt removal
of defective/ recalled product from, the market.
2. The Quality Control Manager is responsible for the
assignment of Qualified Recall Team and determining the
recall strategy.
3. The recall team Leader is responsible for execution and
coordination of all recall activities and to evaluate the
effectiveness of the recall in a suitable interval.
4. The Recall Team is responsible to carry out all recall
activities under the supervision of Recall Team Leader.

35. Recall Procedure
 Product recall management:
1. Product should settle a center to collect and store all
returned stocks of the recalled product;
2. All needed data, quantity and nature of product
shall be noted down by this center as records;
3. Depending on the class of product recall, the
procedure should manage the most effective and
appropriate mode of transportation of recalled
products;

36. Recall Procedure
4. All stocks of the recalled products will be stored
separately in a different section of the warehouse to
prevent any mix-up.
5. The producer has to prepare a progress report of the
recall including the reconciliation between the
delivered and recovered quantities.
 A recalling firm is responsible for promptly notifying
each of its affected direct accounts about the recall.
 A public notification of recall shall be issued by the
regulatory authority.

37. Returned goods
 They are finished product sent back to the
manufacturer from the market.
 Types of returned goods:
1. Date expired goods.
2. Damaged or broken primary containers.
3. Leaky or broken seals of primary containers.
4. Mutilated labeling : product unidentifiable.
5. Soiled labeling : product identifiable.
6. Voluntary Product recall.
7. Product recall on the advice of drug controller
authority.

38. Handling of returned goods
 Products returned from the market should be
destroyed unless it is certain that their quality is
satisfactory.
 In such cases they may be considered for resale or
relabeling, or alternative action taken only after they
have been critically assessed by the quality control
function in accordance with a written procedure.

39. Handling of returned goods
 The nature of the product, any special storage
conditions it requires, its condition and history, and
the time elapsed since it was issued should all be
taken into account in this assessment.
 Where any doubt arises over the quality of the
product, it should not be considered suitable for
reissue or reuse.
 Any action taken should be appropriately recorded.