Research · 6 min read
What an FDA Inspection May and May Not Look At
The inspection power is written down, and so are its limits. Four categories of data are carved out of it by statute, and several kinds of establishment are carved out of the broadest part of it entirely.
Key takeaways
- Entry requires designated personnel presenting credentials and a written notice, and each inspection must be commenced and completed with reasonable promptness.
- For drug establishments the inspection extends to all things therein, including records, files, papers, processes, controls and facilities bearing on adulteration, misbranding or violation of the act.
- The statute excludes financial data, sales data other than shipment data, pricing data, and most personnel data from the inspection power.
- Research data is also excluded, subject to a large exception for data on new drugs, antibiotic drugs, devices and tobacco products subject to the named reporting and inspection regulations.
- Pharmacies meeting stated conditions, practitioners compounding solely for their own practice, and persons making drugs solely for research, teaching or chemical analysis and not for sale sit outside the broad records power.
- Refusing entry or inspection is itself a prohibited act under the food and drug law, separate from any finding about a product.
Answer first: entry needs credentials and written notice, and refusal is its own offense
The authority is 21 U.S.C. 374. Officers or employees duly designated by the Secretary, "upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge," are authorized to enter, at reasonable times, "any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction," or any vehicle used to transport or hold such articles in interstate commerce.
The second half of that authority is the inspection itself: to inspect, "at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein."
Two administrative details are in the same paragraph. A separate notice is required for each inspection, though not for each entry during the period an inspection covers. And "Each such inspection shall be commenced and completed with reasonable promptness."
Refusing has a consequence that sits in a different section. The prohibited-acts list at 21 U.S.C. 331 includes, as paragraph (f), one sentence: "The refusal to permit entry or inspection as authorized by section 374 of this title." Refusal is a violation in its own right, independent of anything an inspection might have found.
For drug establishments, the scope is deliberately wide
For most establishments, the inspection covers the premises and the materials. For drug establishments it goes further, and the statute says so in a sentence written for that purpose.
In the case of any factory, warehouse, establishment or consulting laboratory in which prescription drugs, nonprescription drugs intended for human use, devices or tobacco products are manufactured, processed, packed or held, "the inspection shall extend to all things therein (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs, nonprescription drugs intended for human use, devices, or tobacco products which are adulterated or misbranded within the meaning of this chapter, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this chapter, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this chapter."
All things therein, including records, files and papers, is about as broad as statutory language gets. The limiting phrase is bearing on — the material has to relate to whether the articles are adulterated or misbranded, or otherwise to a violation of the act.
Four categories the statute puts out of reach
Immediately after that broad sentence, the same paragraph narrows it. "No inspection authorized by the preceding sentence or by paragraph (3) shall extend to financial data, sales data other than shipment data, pricing data, personnel data (other than data as to qualification of technical and professional personnel performing functions subject to this chapter), and research data."
Read the exclusions individually, because each is drawn with a deliberate edge. Financial data is out entirely. Sales data is out except shipment data — so where product went is inspectable, but what it sold for and to whom, commercially, is not. Pricing data is out. Personnel data is out except data on the qualifications of technical and professional personnel performing functions subject to the act, which is exactly the kind of record the manufacturing regulations require to exist.
Research data is out as well, but with the largest exception attached: it does not cover data relating to new drugs, antibiotic drugs, devices and tobacco products subject to reporting and inspection under regulations issued under the named statutory provisions, or data relating to other drugs or devices that in the case of a new drug would be subject to reporting or inspection under those regulations.
The practical shape of this is worth stating plainly. An inspection is an instrument for answering questions about product quality and legal status. It is not an instrument for auditing a company's finances or pricing, and the statute says so.
Who is outside the records sentence altogether
The wide records power for drug establishments does not apply to four classes, and the first of them describes an ordinary pharmacy.
It excludes "pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail."
Every clause in that sentence is a condition. Conformance with local pharmacy law. Regular dispensing on prescriptions from practitioners treating patients under their care. And no manufacturing, preparing, propagating, compounding or processing for sale other than in the regular course of retail dispensing — expressly including through a subsidiary. The exclusion describes an activity, not a sign over a door.
The other three classes are practitioners licensed to prescribe or administer who make or compound drugs "solely for use in the course of their professional practice"; persons who make or process drugs or devices "solely for use in research, teaching, or chemical analysis and not for sale"; and any other classes the Secretary exempts by regulation on a finding that inspection is not necessary for the protection of the public health.
What the inspector has to leave behind
The statute also imposes duties running the other way. On completion of an inspection of a factory, warehouse, consulting laboratory or other establishment, and before leaving the premises, the officer "shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, tobacco product, or cosmetic in such establishment (A) consists in whole or in part of any filthy, putrid, or decomposed substance, or (B) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health." A copy goes promptly to the Secretary.
There is a routing rule attached. Where the establishment manufactures a drug approved under the named subsections for which a discontinuance notification has been submitted, or which is or has been in the last five years on the drug shortage list, a copy of the report also goes promptly "to the appropriate offices of the Food and Drug Administration with expertise regarding drug shortages."
If samples were taken, the officer must, before leaving, "give to the owner, operator, or agent in charge a receipt describing the samples obtained." For food establishments specifically, where a sample is analyzed for filth or unfitness, a copy of the results must be furnished promptly to the owner or operator.
Separately, subsection (e) provides that every person required to maintain certain records, and every person in charge or custody of them, "shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records."
How this changes what an inspection document can tell you
Because the scope is defined, the absence of a subject in an inspection record is often a fact about the statute rather than about the company. An inspection that says nothing about pricing is not evidence that pricing was clean; pricing data is outside the inspection power. The same is true of financial data and of most sales data.
Because refusal is its own prohibited act, a document describing a refused or limited inspection is describing something distinct from a finding about a product. And because the pharmacy exclusion turns on activity — particularly on whether the establishment prepares or compounds for sale beyond the regular course of retail dispensing — the same physical building can sit inside or outside the broad records power depending on what it does.
The written report the inspector must leave has a narrow statutory subject: conditions or practices indicating filthy, putrid or decomposed substances, or preparation, packing or holding under insanitary conditions. This article makes no claim about what FDA's inspection forms contain in practice, which is a question about agency documents rather than about this statute.
What the statute reliably supplies is a set of boundaries. Knowing them is the difference between reading an inspection record for what it covers and reading silence as reassurance.
Sources
- 21 U.S.C. 374 — Inspection (subsections (a) through (e))The credentials and written notice requirement, the description of places and vehicles that may be entered, and the scope of what may be inspected; the separate-notice rule and the reasonable-promptness requirement; the extended records scope for establishments handling prescription drugs, human nonprescription drugs, devices or tobacco products; the exclusion of financial data, sales data other than shipment data, pricing data, personnel data and research data, together with the qualifications and new-drug exceptions; the four classes excluded from the extended records scope, including the full text of the pharmacy condition; the written report the inspector must give before leaving and its statutory subject matter; the routing of copies to FDA offices with drug shortage expertise in defined cases; the receipt for samples; the furnishing of analysis results for food samples; and the records access provision in subsection (e).
- 21 U.S.C. 331 — Prohibited acts (paragraph (f))That refusal to permit entry or inspection as authorized by section 374 is itself listed as a prohibited act.
Frequently asked questions
What does an FDA inspector need in order to enter?
The statute authorizes entry by officers or employees duly designated by the Secretary upon presenting appropriate credentials and a written notice to the owner, operator or agent in charge. A separate notice is required for each inspection, though not for each entry during the period the inspection covers, and each inspection must be commenced and completed with reasonable promptness.
Can an inspection look at company records?
For establishments where prescription drugs, human nonprescription drugs, devices or tobacco products are manufactured, processed, packed or held, the inspection extends to all things therein — including records, files, papers, processes, controls and facilities — bearing on whether such articles are adulterated or misbranded, or otherwise bearing on violation of the act.
What is off limits?
The statute excludes financial data, sales data other than shipment data, pricing data, personnel data other than data on the qualifications of technical and professional personnel performing functions subject to the act, and research data — with a substantial exception for research data relating to new drugs, antibiotic drugs, devices and tobacco products subject to reporting and inspection under the named provisions.
Are pharmacies subject to the same records inspection?
Not to the broad records sentence, provided they meet the stated conditions: conformance with applicable local laws regulating pharmacy and medicine, regular dispensing on prescriptions from practitioners treating patients under their care, and no manufacturing, preparing, propagating, compounding or processing of drugs or devices for sale — including through a subsidiary — other than in the regular course of dispensing or selling at retail.
What is an inspector required to give the company?
Before leaving the premises, a written report setting out any conditions or practices observed that in the inspector's judgment indicate an article consists in whole or part of filthy, putrid or decomposed substance, or has been prepared, packed or held under insanitary conditions. A copy goes promptly to the Secretary. If samples were taken, a receipt describing them must also be given before leaving.
What happens if a company refuses an inspection?
Refusal to permit entry or inspection as authorized by the inspection statute is listed as a prohibited act in its own right. It is a separate violation from anything the inspection might have found.