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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Chapter 2 Administration

Chapter 2 Administration

Subchapter 240 - BUSINESS RELATIONS, ETHICS, CONDUCT AND SECURITY 

 

CONTENTS

Subchapter 240 - BUSINESS RELATIONS, ETHICS, CONDUCT AND SECURITY 
241 EQUIPMENT: CARE, CUSTODY, LOSS
242 OFFICIAL CREDENTIALS, BADGE
243 BUSINESS CARDS
244 EMPLOYEE CONDUCT
245 INTERACTION WITH OTHER GOVERNMENT OFFICIALS
246 IMPROMPTU SPEECHES

 SUBCHAPTER 240 - BUSINESS RELATIONS, ETHICS, CONDUCT AND SECURITY

 241 EQUIPMENT: CARE, CUSTODY, LOSS

To perform inspectional and investigative duties during international assignments requires most of the same equipment as domestic work. In most cases, obtain all necessary inspectional equipment from your district office (e.g., cameras, stop watches, thermometers, etc.). DFI can provide a micro cassette recorder upon request. Loaned recorders must be returned to DFI Batteries and tapes should be purchased when necessary and can be claimed on travel voucher.

Assure that all equipment is functional (including proper calibration) prior to departing on the trip. If, while in travel status, minor repairs to equipment are necessary they should be obtained locally, and reimbursement claimed. Major repairs should be deferred.

If equipment is lost, stolen, destroyed, or damaged beyond repair or salvage, immediately forward a memorandum to the appropriate custodial officer of that equipment (district or DFI) showing:

  1. A full description of the article, including the FDA property number, serial number (where applicable), and cost.
  2. The facts and circumstances surrounding the loss, theft, damage or destruction.
  3. The action taken to recover the article when lost or stolen.

 242 OFFICIAL CREDENTIALS, BADGE

Travelers should carry their FDA credentials, but not display their badge during international travel. Credentials should be guarded as you would other valuables.

Should credentials become lost or stolen, be guided by the IOM for further guidance.

Do not allow firms to photograph or make other unauthorized uses of your credentials. In most cases the firm is aware that you are coming, however, your credentials should be presented
at the beginning of each inspection as a means of official identification.

 243 BUSINESS CARDS

Business cards for International Inspection cadre members is a reimbursable expense. It is recommended that all FDA travelers use business cards. They are helpful in providing name and address recognition and they usually prompt the responsible individuals in plants to exchange business cards.

 244 EMPLOYEE CONDUCT

Remember that investigators are the eyes and ears of FDA and may be the only contact a firm has with FDA. The investigator's actions may be the basis upon which they judge the entire agency, and Americans in general. Therefore, it should go without saying that exemplary behavior and conduct is a must. This responsibility applies to both on and off the job activities.

Diplomacy is important when working overseas. It is important to become familiar with local customs and avoid offending firm personnel, especially with inadvertent remarks or jokes.

Occasionally firms may offer gifts of goodwill. Travelers must use discretion and graciously refuse such gifts. The travelers must pay for all hotels, airplane tickets, etc. If the firm pays for such services on your behalf, the cost must be reimbursed immediately. Any services that the firm provides and pays for (such as transportation between the firm and the traveler's hotel, meals, telex/telephone usage, travel services, etc.) must be reimbursed by the traveler. The traveler will, be able to voucher these expenses, provided they are reimbursable.

In the interest of saving time and avoiding confusion, firms inspected will be requested to provide investigators with local transportation to their facility. Transportation by firm employees, where there is no cost involved, are acceptable.

If firms hire a car or commercial transportation for transport, the investigator must pay the fare.

Lunches provided by the firm during the course of the inspection where there is little, or no costs involved are acceptable. Regarding after hours dinners, it may be difficult, but every effort should be made to pay an equitable share of meal charges.

Payment of travel expenses (e.g., tickets, hotel charges, etc.) and receipt of gifts (e.g. tickets to shows, art work, jewelry, etc.) from regulated industry is not allowed. Therefore, decline such payment, gifts and/or tickets presented by management (including their agents) of firms being inspected unless repayment can be arranged. Sometimes, however, payment of travel expenses by regulated industry may be completely beyond the control of FDA and/or the traveler.

For example, an investigator was checking out of a hotel early one morning to catch an early flight to the next destination. When he attempted to pay the bill he was informed the bill had been paid by the last firm he had inspected. Due to the hour of the day and his need to catch his flight, he was unable to contact the firm to make repayment.

If an unavoidable situation such as this occurs, obtain a receipt of the transaction. Upon return, complete a memorandum explaining in detail the circumstances, why repayment was not possible and write a personal check to the company/person who paid the bill. This cannot be claimed on the original voucher but can be claimed separately after the check is cashed.

When acceptance of a gift (e.g. jewelry, art work, etc.) is unavoidable, contact the Administrative Officer and/or Property Custodial Officer for reporting instructions. Turn in the gift and complete all appropriate forms. All gifts become the property of the U.S. Government and must be turned-in and reported to GSA.

Refer to the IOM for further guidance for additional information regarding employee conduct.

 245 INTERACTION WITH OTHER GOVERNMENT OFFICIALS

Occasionally, FDA investigators may be accompanied by an official from the government counterpart authority in the country where the inspection is being conducted. Any such accompaniment will be pre-arranged by DFI and the Investigator should be aware of it prior to the inspection. If accompanied by a government counterpart during inspections, you should document it in a memo and note it in the EIR(s).

 246 IMPROMPTU SPEECHES

On occasion, an investigator may be asked to speak on topics related to FDA to any number and types of officials. Unless you are thoroughly knowledgeable on the subject, politely decline the offer and inform the requester that you will submit the speech request to DFI.

However, if you are thoroughly knowledgeable on the subject, you may at your discretion, and if time and other factors permit, provide such a presentation. If the presentation involves attendees from outside of the firm being inspected (such as foreign government officials or international trade organizations) you should document it in a memo that is submitted to DFI.