LL - Adverse Event Standard Operating Procedure

CONSUMER PRODUCT COMPLAINTS including Adverse Events SOP 


To define the requirements for handling consumer complaints of dietary

Supplements.


*All complaints regarding a product should be documented, even when an “adverse event” isn’t reported. Serious adverse events must be reported to the FDA. 


II. SCOPE

The procedure described here applies to all consumer complaints which involve

failure of any product to meet any of its specifications, including complaints of adverse reactions, illness, or injury.


Product complaint means any communication that contains any allegation, written,

electronic, or oral, expressing concern, for any reason, with the quality of a dietary supplement, that could be related to current good manufacturing practice.


Examples of product complaints are foul odor, off taste, illness or injury - (non-serious or serious), disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, sub potent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead).


III. RESPONSIBILITIES

A. The responsibility for collecting and managing consumer complaints is assigned primarily to the Customer Happiness Team.

B. In order to address consumer complaints effectively, the Customer Happiness Team is dependent on proper documentation of all steps associated with the production, testing, and distribution of finished products by the appropriate departments.

C. Production and Warehouse Management will provide assistance to the Customer Happiness Team with any investigations on consumer complaints.


IV. PROCEDURE

A. A qualified member of the Customer Happiness Team must review EACH consumer complaint to determine whether the complaint involves a possible failure of a dietary ingredient or dietary supplement to meet any of its specifications or any other requirements that may render the product non-conforming and a possible risk of illness or injury to the consumer.

B. The Customer Happiness Team must review and approve decisions to investigate a product complaint, and they must review and approve the findings and follow-up action of any investigation performed.

C. Review, investigations, and follow-up action for product complaints must extend to all relevant batches and records.

D. If the review indicates that the product is a possible risk to consumer safety, the consumer complaint must be fully investigated, and the need to recall the product must be evaluated.

E. The investigator must review the batch records associated with the dietary supplement involved in the consumer complaint. 

The investigator must review batch records for other dietary supplements that may have also been affected and could also pose a threat to consumer safety.

F. The Customer Happiness Team must maintain a written record of every consumer complaint, whether the complaint relates only to product quality, or to concerns about a possible health hazard.

G. Records of every consumer complaint must be maintained even if documentation exists to show that the product was produced in conformance with good manufacturing practices.

H. Written records of a consumer complaint must include, but are not limited to, the following:

1. Complaint number (for tracking purposes)

2. Name and description of product

3. Batch, lot, or control number (if available)

4. Complaint date

5. The manner in which the complaint was received

6. Complainant’s name, address, telephone number (if available)

7. Nature of complaint and how the product was used (if applicable)

8. Findings of investigation and follow-up action

9. All correspondence associated with the complaint

10. Initials

11. Dated reviewer’s initials

I. Records of investigations involving complaints of possible hazard to health must be complete showing that all requirements for the investigation were met. These records must also show dates, times, and the names of all individuals involved with the investigation.

J. The Customer Happiness Team must maintain a written record of each consumer complaint for at least one year after the expiration or shelf life date of the product, or one year after the date that the complaint was received, whichever is longer. For product complaints involving a serious adverse event report, the complaint records must be maintained for a minimum of 6 years past the date of the adverse event report.

K. Consumer complaint records may be maintained as original records, reproductions, or as electronic copies. Electronic records must comply with the Code of Federal Regulations (21 CFR Part 11) for Electronic Records and Electronic Signatures.

L. Consumer complaint and adverse event records must be readily available during the retention period of 6 years, for authorized inspections by the FDA.

M. Reports should be filed on the MEDWATCH 3500A form within 15 business days at: http://www.fda.gov/Food/DietarySupplements/ReportAdverseEvent/default.htm


About adverse events: 

The manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States is required to submit to the FDA all "serious adverse event" (defined below) reports associated with the use of the dietary supplement in the United States.  Section 761(b)(1) of the FD&C Act (21 U.S.C. 379aa-1(b)(1)).  


You are not required to submit anything to the FDA for something that is merely an "adverse event" (defined below), however, you are required to keep records regarding all adverse events (which will be discussed more fully below).


The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 ("the Act") usually refers to the entity that is required to submit a serious adverse event report to FDA as the "responsible person."  


Accordingly, I will use the term "responsible person" as an alternative to "manufacturer, packer, or distributor." 


You can find the entire text of the Act at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/ucm148035.htm . 


An "adverse event" (as opposed to a "serious adverse event") is defined as "any health-related event associated with the use of a dietary supplement that is adverse."  Section 761(a)(1) of the FD&C Act (21 U.S.C. 379aa-1(a)(1)).  


As I mentioned above, although the Act does not require you to report an adverse event, it does require you to keep records of it. 


If you receive a report of a non-serious adverse event associated with a dietary supplement for which you are the responsible person, you must keep the report along with any related records (e.g., records of your communications with the person(s) who reported the adverse event to you, records of your assessment of the event as non-serious).  


All such records of non-serious adverse events must be kept for six years, just like records of serious adverse events.  Section 761(e)(1) of the FD&C Act (21 U.S.C. 379aa-1(e)(1)).


A "serious adverse event" is defined as an adverse event that:

  • Results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect; or
  • Requires, based on a reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.

Agent procedure for training: 

  • ALL product complaints, including product defects, and adverse events must be documented and archived for up to 6 years.
  • The receiving agent will notate the complaint on the Adverse Event Tracker located in the Learning Library/Adverse Events and on the CHO.
  • When a customer reports any type of “reaction” to a product, we process a refund immediately.
  • In cases of minor complaints and the customer is not visibly upset, where there is the remaining unopened product we will send return instructions.
  • Where there is a potentially serious reaction, or where they visited an ER, doctor, or hospital...we will NOT ask them to return the remaining product.

NOTE: Any adverse event that meets the requirements for a Serious Adverse Event, should be reported to the Team Lead immediately. 


Defective Product Procedure: 

All product complaints including product defects and adverse events should be documented and archived for up to 6 years. 


Defective products may be a foul odor, off taste, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a dietary supplement container, improper packaging, mislabeling, or dietary supplements that are superpotent, sub potent, or contain the wrong ingredient, or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead). 

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Process:

#1 Apologize. Ask the customer to take a picture of the product and email it to us, this is for Quality Assurance purposes. We may need to contact our manufacturer. 

#2 Ask the customer NOT to dispose of the product, please keep it until we contact them with further instructions. We may ask them to mail it back to us and we will pay for the postage if we do.

(If so, it will be sent to the Headquarters address - not the warehouse) - contact your team lead about this.

#4 Arrange to send the customer a replacement product immediately.

#5 Accurately note the complaint using the Adverse Event Tracker located  https://forms.gle/ZU3YbsiDUmm83P2VA

#6Notate the complaint and resolution in the customer record/ticket. 

#7 Alert Manager to determine if we need the defective product to be returned.

#8  If the customer had an illness or injury - (non-serious or serious), this must also be documented under the Adverse Event Reporting Act.  

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