21 CFR 111.560: What requirements apply to the review and investigation of a product complaint?
Requires a qualified person to review every product complaint and investigate any suggesting a specification or Part 111 failure, with quality control approving investigation decisions, findings and follow-up, covering all relevant batches and records.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart O, Product Complaints
Recent 483s citing 111.560
- Aspire Pharmaceuticals Inc. · Somerset, New JerseyFeb 3, 2022
- Hello Life, Inc · Kentwood, MichiganA qualified person did not review a product complaint to determine whether the… Mar 7, 2019
- Pharmatech LLC · Davie, FloridaA qualified person did not investigate a product complaint that involved a possible… May 2, 2017
- BLA Enterprises, LLC · Lakewood, ColoradoInvestigations into deviations from approved processes do not always include a root… Dec 8, 2016
- Nutri-Dyn Midwest, Inc · Maple Plain, MinnesotaA qualified person did not review a product complaint to determine whether the… Apr 10, 2015
The regulation text
§ 111.560 What requirements apply to the review and investigation of a product complaint?.
(a)A qualified person must:
(1)Review all product complaints to determine whether the product complaint involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part 111, including those specifications and other requirements that, if not met, may result in a risk of illness or injury; and
(2)Investigate any product complaint that involves a possible failure of a dietary supplement to meet any of its specifications, or any other requirements of this part, including those specifications and other requirements that, if not met, may result in a risk of illness or injury.
(b)Quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and followup action of any investigation performed.
(c)The 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 followup action of any investigation performed, must extend to all relevant batches and records.
Questions
What does 21 CFR 111.560 require?
Requires a qualified person to review every product complaint and investigate any suggesting a specification or Part 111 failure, with quality control approving investigation decisions, findings and follow-up, covering all relevant batches and records.
Which sections are cited alongside 111.560?
In the same 483s, investigators most often also cite 211.160 (General requirements), 211.192 (Production record review), 211.22 (Responsibilities of quality control unit), 211.67 (Equipment cleaning and maintenance).