The copy you provide need not be signed by the issuing judge, but the judge's name should be typed on the copy.

Follow the procedures of the court or U.S. Attorney involved, if their methods differ from the above.

When an inspection is made pursuant to a warrant, a Return showing the inspection was completed must be made to the Judge (or U.S. Commissioner or Magistrate) who issued the warrant. The Return, executed on the original warrant, should be made promptly and usually no later than 10 days following its execution.

516 - DISCUSSIONS WITH MANAGEMENT

After completion of the inspection, meet with the highest ranking management official possible to discuss your findings and observations. The FDA 483 is not a substitute for such discussion since there may be additional questionable practices or areas not appropriate for listing on this form.

During the discussion be frank, courteous and responsive with management. Point out the observations listed on the FDA 483 are your observations of objectionable conditions found during the inspection, and explain the significance of each. Try to relate each listed condition to the applicable sections of the laws and regulations administered by the FDA. You should inform management during the closeout discussion the conditions listed may, after further review by the Agency, be considered to be violations of the Food, Drug and Cosmetic Act. Legal sanctions, including seizure, injunction, civil money penalties and prosecution, are available to FDA if establishments do not voluntarily correct serious conditions.

Do not be overbearing or arbitrary in your attitude or actions. Do not argue if management voices a different view of the FDA 483 observations, or of your opinions. Explain, in your judgment the conditions you observed MAY be determined by the FDA, after review of all the facts, to be violations. Make clear the prime purpose of the discussion is to call attention to objectionable practices or conditions, which should be corrected.

Obtain management's intentions regarding correcting objectionable conditions. They may propose corrections or procedural changes and ask you if this is satisfactory. If this involves areas where your knowledge, skill, and experience are such that you know it will be satisfactory, you can so advise management. Do not assume the role of an authoritative consultant. In areas where there is any doubt, you must explain to management you cannot endorse the proposed corrections. Advise the individuals FDA will supply comments if the establishment will submit its request and its proposed corrections or procedures in writing to the district office.

Concentrate on what needs to be done rather than how to do it. Do not recommend the product or services of a particular establishment. If asked to suggest a product or consulting laboratory, refer the inquirer to a classified directory or trade publications and or organizations.

Report in your EIR all significant conversations with management or management representatives. In most instances it is not necessary to quote management's response verbatim. Paraphrasing the replies is sufficient. However, if the situation is such that quoting the reply or replies is necessary, enclose them in quotation marks.

516.01 - Protection of Privileged Information

You have certain responsibilities under the FD&C Act, Section 301(j); Sections 359(d) & 306(e) of the Public Health Service Act; and Section 1905 of the Federal Confidential Statute (18 U.S.C. 1905) regarding protection of confidential material obtained during your official duties. See IOM 130.

Do not volunteer information about other firms or their practices. Ignore casual exploratory questions or remarks from management about competitors or their processes. Your casual and seemingly innocuous remarks may reveal privileged information. Therefore, be alert and avoid voluntarily or unknowingly divulging information, which may be privileged or confidential and possibly compromise FDA's and your own integrity.

Management often request copies of any documents or records you obtain from their firm. There is no objection to your supplying these. When management requests copies of photos taken by you in a plant, follow IOM 523.03.

You may encounter situations when management invites outside individuals to observe the inspectional process (e.g., representatives from the press, trade associations, congressional staff, other company officials). As discussed in Section 504.03 of the IOM, the presence of representatives invited by the firm should not disrupt the inspectional process. You are to continue the inspection in a reasonable manner.

If the firm allows invited individuals to photograph, videotape, or prepare audio recordings during the inspection, you should make every effort to protect privileged information in your possession. However, it is the Agency's position that it is the firm's responsibility to protect confidential and/or proprietary information observed or recorded by those individuals invited by the firm. Where applicable, refer to IOM 524 for additional procedures on how to prepare your own recording in parallel with the firm's recording.

516.02 - Refusals of Requested Information

Should management refuse to provide any reasonable request for information, which is not specifically required by the law, determine the reasons for the denial and report the details in the EIR. Types of refusals of interest to FDA and refusal codes to be entered in FACTS are listed in the FDA Data Codes Manual. Refusal codes' data are used when reporting to Congress. See IOM 514.01 for instructions in dealing with hostile and/or uncooperative interviewees.

517 - CONSUMER COMPLAINTS

Prior to conducting any inspection, you should review the FACTS system and the factory jacket becoming familiar with all FDA Complaint/Injury forms. Be especially alert for ones marked "Follow-Up Next Inspection" and make sure you investigate these during your inspection.

During the inspection, discuss these complaints with management without revealing the complainant's name(s). Determine if the firm has had similar complaints on the same product. Determine what action the firm has taken to identify the root cause of the problem and to prevent a recurrence in the future. See IOM 593.03 for reporting instructions.

518 - INTERVIEWING CONFIDENTIAL INFORMANTS

When you are faced with a situation involving sources of information who want to remain anonymous, please contact your supervisor and follow the procedures here. In addition, refer to IOM 510.01 regarding your personal safety. If your management concurs with the decision to utilize a confidential source, it is particularly important you take the necessary steps to keep the identity of the source, and any information which could lead to the identity, confidential. For purposes of this subchapter, a confidential source is a person who provides information that may be of assistance to FDA without necessarily becoming a party to the actual FDA investigation. If you believe the information provided by the source could lead to a criminal investigation, please contact the Office of Criminal Investigations (OCI).

1. How to handle the first contact. When you interview a person who may become a confidential source use the following procedures.
   1. Type of meeting. Try to schedule a personal interview with the person rather than a telephone interview. At a face-to-face interview you can assess the person's demeanor, body language, overall presentation, and truthfulness.
   2. Meeting location. The place and time of the interview should be the choice of the person, unless there is a concern with personal safety. If the person's suggested location is unsuitable, the investigator should suggest the location. When you conduct the interview off FDA premises, notify your supervisor of your destination, purpose, and estimated time of return. When an off-site interview has been completed, check-in with your supervisor.
   3. Interviewing methods/techniques. It is strongly recommended you have two investigators conduct interviews of a confidential source. The lead investigator conducts the interview, while the second investigator takes notes and acts as a witness to the interview. You should:
      1. prepare carefully for the interview. The investigators should develop the questions they intend to ask the person during the interview, e.g., "establish motivation," and record and number the questions to be asked in their diaries prior to the interview. This preparation assists in documenting the interview process and reduces the amount of note taking needed during the interview. The investigators also should discuss their interviewing strategy, and determine the method by which they will consult with each other during the interview and (during extensive interviews) share the interviewing and note-taking responsibilities;
      2. have the person tell the story chronologically, placing complex situations into logical order; and
      3. if the person makes allegations, ask him or her how he or she knows the allegations are true.
         --How were they in a position to know?
         --Did they personally see, hear, or write about the information/incident?
         --Can they provide proof of the allegations?
   4. Establish motivation. At the end of the interview ask the person why he or she is divulging this information. This may reveal their motive(s):
      1. Is the person a disgruntled current or former employee who harbors a grudge?
      2. Is the person looking for some type of whistle-blower reward or notoriety?
         
      3. Does the person just want to do the right thing?
      4. Is the person involved in actual or prospective litigation about or related to the information?
   5. Anonymity. If the person is requesting anonymity, inform him or her FDA:
   1. will not divulge his or her identity, the occurrence of the interview, or the sensitive information provided to FDA if the information could lead to the identity of the person, unless FDA is required to disclose the information by law, e.g., the investigation leads to a hearing or trial and he or she is required to testify, and
   2. will try to corroborate all information provided by the person, minimizing the chances he or she must later testify. However, testifying remains a possibility.
   6. Ask the person for names of other persons who might be willing to speak with you about the allegations and corroborate their story.
2. Protect the identity of the source.
   
   1. Collection of information. Obtain sufficient personal information necessary to enable you to contact the person for follow up if needed. However, to maintain the confidentiality of the person, do not include the person's identifier information such as gender, name, address, and phone number in the memorandum of interview. You should assign the confidential source a code name or number and use the identifier in memoranda and other communications relating to the confidential source (see item C.2. below).
   2. Access. Know who is authorized by District procedure to access the information, and restrict access by others accordingly. Share the minimum amount of information necessary to meet the purpose of the disclosure.
   3. Storage. Each District should establish procedures, in addition to those listed below, to properly store confidential information. The following list contains information related to storage procedures.
      1. Use security measures necessary to protect the confidentiality of personal information, whether it is in hard copy or electronic form, on FDA premises, in an FDA home-based computer, or in any other form. Use whatever means necessary and appropriate to physically safeguard the information, such as storing in a safe, or locked file cabinets, or password-coded computers, etc.
      2. When referring to the source in any manner (orally, in writing, electronically, etc.), consider using code to identify the source. For example, use a number rather than the individual's name, to identify the source. Personal privacy information should be safeguarded. Use discreet subject headers in the file labels as appropriate.
      3. Remove personal information from a file only after you have noted in the file your name, date, etc. Promptly return that information to the file.
   4. Disclosure. Do not disclose information from or about the source, unless the disclosure complies with the law and FDA's procedures. Do not share non-public information outside of the Freedom of Information (FOI) process, unless the sharing is done according to our regulations and procedures. Refer FOI requests to your FOI officer (see item (3) below). See also IOM Subchapter 130. The following information relates to disclosures of information from or about a confidential source.
      1. Make duplicates of the personal information only to the extent necessary for authorized disclosure (inside or outside of FDA). Do not leave the copy machine unattended.
      2. Make only authorized disclosures of the information, regardless of the manner of disclosing (oral, written, etc.). Do not use mobile telephones or leave voice mails with the information. Avoid transmitting the non-public information by facsimile or e-mail.
      3. If you receive a FOI request for information from or about a source consult with your supervisor immediately Disclosure to a non-FDA government official of information from or about a source may be disclosed only if permitted by law and FDA procedures, and after consulting your supervisor and, if needed, OCI.
      4. Immediately retrieve information from or about a source is inadvertently disclosed.
   5. Destruction. Destroy personal information by shredding or similar means which physically destroys the record and/or, if the information is in electronic form, makes it unreadable.
      Office of Chief Counsel. After a matter has been referred to the Office of Chief Counsel (OCC) for litigation or enforcement action, consult with OCC if you are interested in contacting the source.