PART IX: Product Complaints Written Procedures

Introduction
This month we will discuss how to review, process and document product complaints. Complaints related to cGMP product quality include super-potent, sub-potent, wrong ingredient, and contaminant. Examples of these include bacteria, pesticide, toxin, glass, lead, and drug among others. Consumer quality complaints that are unrelated to cGMP have to do with the safety of a particular dietary ingredient. This is independent of whether the product is produced under cGMP.

Guidelines for Product Complaints: Review and Investigation
A qualified person must:
• Review all product complaints to determine whether the complaint involves a possible failure of a dietary supplement to meet any of its specifications or any other cGMP requirements that, if not met, may result in a risk of illness or injury
• Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications or any other requirement that, if not met, may result in a risk of illness or injury
Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed.
Review and investigation of the product complaint by a qualified person, and the review by quality control personnel about whether to investigate a product complaint, and the findings and follow-up action of any investigation performed, must extend to all relevant batches and records.

Guidelines for Product Complaints: Records to draft or keep
Written procedures for fulfilling the requirements of Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
A written record of every product complaint that is related to good manufacturing practice
Person who performs the requirements of this subpart must document, at the time of performance, that the requirement was performed
• The written record of the product complaint must include the following
• Name and description of dietary supplement
• Batch, lot, or control number of the dietary supplement, if available
• Date the complaint was received
• Name, address or telephone number of complainant, if available
• Nature of the complaint including if known, how the product was used
• The reply of the complainant, if any
• Findings of the investigation and follow-up action taken when an investigation is performed

Guidelines for Product Complaints: Requirements applied to the records that you make and keep
Written records for Product Complaints are required for 1 year past the shelf life date, if shelf life dating is used, or 2 years beyond the date of distribution of the last batch of dietary supplements
Records must be kept as original records, as true copies (such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records), or as electronic records

Guidelines for Product Complaints: Records to be made available to FDA
All records for Product Complaints, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested
If you use reduction techniques, such as microfilming, you must make suitable reader and photocopying equipment readily available to FDA