{"results":[{"id":"chapter-01--1-9-1","chapter_id":"chapter-01","section_ref":"1.9.1","title":"Credentials/Badges","source_url":"https://www.fda.gov/media/166528/download?attachment","snippet":"SMG 2280.3 provides instructions for the issuance and control of FDA Credentials and Badges including\nexpiration, renewal, transfer, separation, and retirement. Contact your supervision and fda-..."},{"id":"chapter-05--5-1-4","chapter_id":"chapter-05","section_ref":"5.1.4","title":"Responsibilities of Investigators","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Section 704 of the FD&C Act sets requirements on how you should conduct inspections.\nAccordingly, it is your responsibility to conduct all inspections at reasonable times, within reasonable limits,..."},{"id":"chapter-05--5-1-2","chapter_id":"chapter-05","section_ref":"5.1.2","title":"Inspectional Approach","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Your inspectional approach may vary depending on the reason or basis for the inspection. You should determine,\nduring your preparation, what type of approach will work best and prove most effective..."},{"id":"chapter-05--5-2-8","chapter_id":"chapter-05","section_ref":"5.2.8","title":"Travel Coordination and Planning","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Travel is an integral part of inspections. As such, it needs to be planned and well-coordinated to go smoothly. (See IOM\n1.2 OII Travel for information regarding travel authorizations using ConcurGOV..."},{"id":"chapter-05--5-5-1","chapter_id":"chapter-05","section_ref":"5.5.1","title":"Notice of Inspection (Form FDA 482)","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Upon arrival at the firm, you should first locate the owner, operator, or agent-in-charge of the establishment. This\nshould be the top management official on site, and you should be certain of this..."},{"id":"chapter-04--4-2-1","chapter_id":"chapter-04","section_ref":"4.2.1","title":"Dealer Definition and Good Will","source_url":"https://www.fda.gov/media/166532/download?attachment","snippet":"For sample collection purposes, the dealer is the person who has possession of a particular lot of goods.\nThe dealer does not have to be a firm or company in the business of buying or selling goods...."},{"id":"chapter-09--9-2-15","chapter_id":"chapter-09","section_ref":"9.2.15","title":"U.S. Postal Service (USPS)","source_url":"https://www.fda.gov/media/166531/download?attachment","snippet":"The Postal Service’s mission is to provide the nation with reliable, affordable, universal mail service. By\nlaw, its basic function is “…. to bind the Nation together through the personal,..."},{"id":"chapter-09--9-3-1","chapter_id":"chapter-09","section_ref":"9.3.1","title":"SLTT OPERATIONAL AUTHORITY","source_url":"https://www.fda.gov/media/166531/download?attachment","snippet":"All states and local governments have established jurisdiction over many establishments that\nmanufacture, process, pack, hold or sell FDA-regulated products. The authority extends to\nestablishments,..."},{"id":"chapter-05--5-6-3","chapter_id":"chapter-05","section_ref":"5.6.3","title":"Individual Responsibility","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Always determine and report the full legal name, title, mailing address, and email address of the top management\nofficial(s) to whom FDA official correspondence, including FMD-145 correspondence,..."},{"id":"chapter-05--5-5-3","chapter_id":"chapter-05","section_ref":"5.5.3","title":"Inspection Warrant","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"A refusal to permit inspection or a refusal to permit access to or copying of records may invoke criminal provisions of\nsections 301(e) and 301(f) of the FD&C Act [21 U.S.C. 331(e), (f)]...."},{"id":"chapter-10--10-9","chapter_id":"chapter-10","section_ref":"10.9","title":"PPE","source_url":"https://www.fda.gov/media/166537/download?attachment","snippet":"PPE is protective clothing and equipment designed to reduce exposure to hazards and/or harm caused\nby hazards, prior to an exposure. You should identify and evaluate all hazards prior to selecting..."},{"id":"chapter-05--5-10-3","chapter_id":"chapter-05","section_ref":"5.10.3","title":"Counterfeit Drug Authority","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"Section 702(e) of the FD&C Act [21 U.S.C. 372(e)] contains certain authorities relating to counterfeit drugs including\nthe authority to seize (\"confiscate\") counterfeit drugs and containers,..."},{"id":"chapter-05--5-8-2","chapter_id":"chapter-05","section_ref":"5.8.2","title":"Personnel","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"5.8.2.1 – Management\nFollow the guidance described in IOM 5.6.3 when documenting individual responsibility, including obtaining the\nfull name and title of the following individuals:\n• Owners,..."},{"id":"chapter-05--5-2-9","chapter_id":"chapter-05","section_ref":"5.2.9","title":"Team Inspections","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"The use of teams to conduct inspections may be beneficial. Note that a team may consist of multiple investigators, as\nwell as laboratory personnel, other FDA employees, and your supervisor, who may..."},{"id":"chapter-03--3-2-3","chapter_id":"chapter-03","section_ref":"3.2.3","title":"Authority to Inspect","source_url":"https://www.fda.gov/media/166530/download?attachment","snippet":"Section 704 of the FD&C Act [21 U.S.C. 374] provides the basic authority for establishment inspections.\nThis authorizes you, upon presenting appropriate credentials and a written notice (FDA-482,..."},{"id":"chapter-05--5-5-2","chapter_id":"chapter-05","section_ref":"5.5.2","title":"Inspection Refusal","source_url":"https://www.fda.gov/media/166533/download?attachment","snippet":"A refusal of inspection is refusal to permit entry or other action that prohibits you from obtaining records and\ninformation to which the FDA is entitled under the law. Discuss all refusals with the..."},{"id":"chapter-04--4-3-4","chapter_id":"chapter-04","section_ref":"4.3.4","title":"Special Sampling Situations","source_url":"https://www.fda.gov/media/166532/download?attachment","snippet":"There will be situations that arise where the dealer may need to sample product for you due to safety\nand/or other concerns. After evaluation of the situation and prior to allowing dealer sampling,..."},{"id":"chapter-06--6-8-1","chapter_id":"chapter-06","section_ref":"6.8.1","title":"FSVP Inspections","source_url":"https://www.fda.gov/media/166534/download?attachment","snippet":"FSVP inspections are conducted to ensure that imported food is produced using processes and procedures that provide\nat least the same level of public health protection as food produced in the United..."},{"id":"chapter-01--1-6-1","chapter_id":"chapter-01","section_ref":"1.6.1","title":"OII Government-Owned Vehicle (GOV)","source_url":"https://www.fda.gov/media/166528/download?attachment","snippet":"GOVs for field operations are furnished by the regional GSA motor pool office. GOV users should follow\nthe operating procedures in effect for the appropriate GSA motor pool. Each District office has..."},{"id":"chapter-04--4-4-4","chapter_id":"chapter-04","section_ref":"4.4.4","title":"Documenting Interstate Shipments","source_url":"https://www.fda.gov/media/166532/download?attachment","snippet":"The minimum set of records ordinarily submitted with an official sample will consist of a copy of the\ninvoice covering the sale of the lot, batch, or unit to the dealer; the transportation record..."}],"limit":20}