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To provide written instructions for inspections from regulatory agencies - having legal authority over our products, including their labels and labeling, marketing and advertising, manufacturing, and associated documentation and practices.
All employees who may be part of inspections from regulatory agencies, or who may come into contact with Inspectors from regulatory agencies are responsible for following this SOP. The Quality & Regulatory Affairs Department is responsible for maintaining all documentation and records associated with inspections from regulatory agencies.
A designated individual to be available and prepared to manage regulatory agency inspections.
Upon initial contact with an Inspector from a regulatory agency: greet them, review their credentials, escort them to a conference room, and immediately notify them that someone will be with them as soon as possible. This conference room should at all times be maintained to be free of inspectable documents that are regulated by any regulatory agency.
The IC is designated as the following people: In the event is unavailable, will coordinate the inspection. The IC should have someone attend and assist with note taking, document gathering and duplication, and facilitating the procedures outlined in this document. The IC greets the Inspector and requests and records the following information:Name of agency.Inspector’s name, identification number, and office.Notice of inspection (if issued by the agency).In the event of an FDA inspection, the document requested will be a “FDA Form 482 – Notice of Inspection”. Specific purpose of the visit.Potential scope and extent of the inspection, including the estimated time required; products, processes, and/or Departments to be reviewed; and anticipated requested documentation.The Inspector’s credentials. The IC and executive management determine if legal counsel is required due to the subject and scope of the inspection.Legal counsel must be contacted if the regulatory agency is alleging a possible injury (e.g., serious adverse event) associated with a product. Every effort must be made to establish a good, professional relationship and to minimize any potential misunderstandings with the Inspector.
If a facility tour or a visit to a specific area is requested, the IC always accompanies the Inspector. The Inspector is limited to seeing those areas of the facility that fall under the jurisdiction of the particular agency or that have been requested due to the scope of the inspection. The FDA is authorized to enter at reasonable times, any factory, warehouse, or establishment in which dietary supplements are manufactured, processed, packed, held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such dietary supplements in interstate commerce. The FDA is authorized to inspect at reasonable times and within reasonable limits and within a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person who manufactures, processes, packs, transports, distributes, or holds dietary supplements, the inspection shall extend to all records and other information described in section 350c (refer to Reference 5.2). The FDA is not authorized to inspect financial data, sales data other than shipment data, pricing data, personnel data (other than data pertaining to the qualifications of technical and professional personnel), and research data. All questions from the Inspector are handled by the IC. If information is required from other employees, the IC arranges for these employees to meet with the Inspector.All employees contacted during the inspection must respond to all questions truthfully and directly, but without any elaboration beyond the specific questions asked. If an employee states that they do not know the answer to a specific question, the IC will inform the Inspector that the appropriate person will be found to respond to the question as soon as possible. Upon entering a specific area, the responsible Supervisor is briefly informed (if necessary) about the purpose of the visit. The Department Manager then accompanies and assists in responding to any questions about their area, as directed by the IC.
The IC or another person is responsible for taking notes during the course of the inspection. The notes may include items such as the date(s) of the inspection, purpose of the inspection, areas of the facility toured, observations noted by the Inspector, all documentation reviewed, samples taken, questions asked by the Inspector, relevant responses given by employees, documentation copied for the Inspector, and any additional comments noted by the Inspector. If the Inspector requests copies of documentation or samples of products, such requests must be very specific to ensure equally specific fulfillment of the requests. If the Inspector requests any documentation, the IC will record each request and inform the Inspector that copies will be provided as soon as possible. If the copies of the requested documents are questionable, responsible management must review as soon as possible after the request by the Inspector. If the documentation cannot be provided, the Inspector is told that management is reviewing the request, and will forward the copies to their office after permission is granted. Copies of documentation provided to the regulatory agency should be marked as “Confidential” if they contain proprietary information. Duplicate copies must be made of all documentation copied for the Inspector. The duplicates are carefully maintained and filed with the inspection notes and records. If samples are collected for the Inspector, duplicate samples are taken and maintained as part of the inspection records.If the Inspector states what tests may be performed on the samples taken, it may be considered by us to have those same tests performed by an independent third-party laboratory.
At the end of the inspection, the IC requests an exit interview with the Inspector.If an exit interview request is granted, it should be attended by the IC, executive management, and other appropriate employees to be determined. If the Inspector issues an observation report, the included items should be discussed.
Immediately following the Inspector’s departure, management reviews the notes and observations about the inspection and identifies violations that may be apparent or suspected. A corrective action plan must be documented for minor and major problems, including the actions to be taken, responsible persons, follow-up checkpoints, and completion dates. If a written response to an inspection is required, the IC will work with executive management and legal counsel to prepare and send a response to the regulatory agency in the requested time. The IC is responsible for preparing and sending any continuing follow-up reports requested by the agency. Copies of all correspondences with the regulatory agency must be maintained in the inspection file by the IC.
PURPOSE
RESPONSIBILITY
DEFINITIONS
Inspection Coordinator
REFERENCES
PROCEDURES
Initial Contact Duties
Inspection Coordinator Duties
@Garret Ma
@Garret Ma
@Katie Spinosa
Facility Tour Requirements
Documentation and Sample Requirements
Exit Interview
Post-Inspection Responsibilities
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