Todd Harrison11.01.02
Impending Dietary Supplement GMPs
In anticipation of FDA’s implementation of GMPs, advice on how to handle an FDA inspection is provided.
By Todd Harrison
As the industry anticipates the publication of FDA's proposed rules regarding dietary supplements, this might be good time to provide a general overview of how a company should handle an FDA inspection. Some things are quite obvious such as being courteous to the person conducting the inspection. Others are not, such as signing an affidavit provided by the agency at the conclusion of the inspection. The following is intended to provide broad general principals in assisting a company in drafting an FDA inspection policy and is not intended to be an all-inclusive list of how a company should handle an FDA inspection. Indeed, every company's inspection policy will be different depending on its particular circumstances.
FDA Inspection Guidelines
DO ensure that the inspector is escorted around the facility at all times with a duly authorized representative of the company, and if at all possible two designated representatives. Prior to any FDA inspection, a company should have a designated official and a team that will escort the inspector(s) during the inspection. A company should designate an individual to notify management immediately of FDA's request to inspect the facilities. Two company officials should at a minimum, attend any conference that is being held between FDA and a company. Additionally, the FDA inspection team must provide the company with a written notice of inspection. Each member of the FDA inspection team must also present his or her credentials at the time of inspection. A company official should write down the name, identification number, title, government unit, business address, telephone number and reason for visit of each inspector. Any agency personnel that fails to present credentials, should NOT be allowed to enter the premises or to participate in the inspection.
DO conduct a pre-inspection conference with the inspectors to ascertain (1) the purpose and scope of the inspection; (2) the areas, materials and records that are of interest to the inspector; (3) any samples that the inspector would like to take with him or her and (4) any testing that the agency desires to perform. During the conference, inform the FDA inspection team that they are required to comply with all company policies, including health and safety rules. Also alert them that any recording or photographic devices are prohibited. Also let them know that they will have an escort at all times. During the initial conference and at the conclusion of the inspection, advise the FDA inspection team of the name, address and phone number of the individual in which all correspondence should be addressed.
DON’T speak to the inspector unless the company or its designated representative(s) authorizes you to do so. If you are unclear whether you should answer a question, or unclear as to the company's policy regarding providing the information requested in the question, simply state this fact to the inspector, ask him to submit the question in writing and forward it to the appropriate person in the company or to the legal staff. Only answer the question asked, and then only to the extent that the question relates to the duties you perform for the company. Answer all questions honestly. If you do not know the answer to a question, then simply state that you do not know the answer. Do not disclose trade secret or confidential information, including information regarding the company's financial matters such as department budgets or spending authority, the corporate organizational structure and the names or titles of management other than individuals under your supervision and your direct supervisor. If the inspection does include areas of the facility in which trade secrets are maintained, orally request that all information from those areas be treated in a confidential manner.
DO take detailed notes of the inspection, including the areas covered and time spent in those areas. Detail the records requested, examined and copied. Note the testing and sampling performed and any comments made by the inspector, yourself or other company employees.
DO allow inspectors to take samples and labeling found on the premises. However, make sure that FDA provides you a written receipt using Form FD-484 for any samples taken.
DON’T let yourself become intimidated into providing information that the agency is not legally entitled to obtain without a subpoena. FDA does not have unfettered access to company records. Rather, it may only request those records that it is legally entitled to under the Federal Food, Drug and Cosmetic Act. If the inspector informs you that he is entitled to a particular record, respectfully decline to provide with the proviso that you would forward any written request to the appropriate individual in the company or to the legal department.
NEVER sign any documents, including affidavits. FDA cannot require you to sign any form nor take legal action against you for refusing to do so.
NEVER admit any wrongdoing, past or present. If an FDA inspector shows up after regular business hours, make every effort to have the inspector return during regular business hours. More specifically, inform the inspector there is no one on the premises authorized to represent the company during the inspection. If the inspector is insistent, attempt to locate the designated personnel within the company. If no one is available, explain it to the inspector and politely advise the inspector to return during normal business hours or when you can arrange to have the company's representative available. If the inspector has a warrant or suspects the existence of an imminent health hazard and continues to insist on performing an inspection, inform him that he will need to wait until the designated personnel are available. Additionally, it is advisable to contact counsel if the inspection is pursuant to warrant or is based on a belief that the existence of an imminent health hazard exists.
Summary
At the completion of the inspection, the FDA inspector will meet with the “owner, operator or agent in charge.”At this time, the FDA inspector provides an FDA form entitled Inspectional Observations (Form FD-483), listing observations the inspector believes are violations. (If the inspector observes no violations, no FD-483 is issued.) This is the best time to discuss the list of observations with the inspector. Promptly after the inspection has been completed, appropriate company personnel should meet to discuss the inspection. Legal counsel also should be consulted. At this time, a determination can be made as to whether a written response to the observations would be productive. After the inspection, the inspector returns to his office and, over the next several days or perhaps weeks, prepares a detailed Establishment Inspection Report (EIR). The EIR becomes FDA's primary record of the inspection and is reviewed by FDA compliance officers. This EIR is available only when FDA has closed its file on the inspection.NW