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Under the Food and Drug Administration Safety and Innovation Act (FDASIA), the U.S. Food and Drug Administration (FDA) may deem a drug adulterated if that drug is “manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”  In October 2014, FDA released “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” a finalized version of a draft guidance FDA published in July 2013, to clarify the conditions under which a drug may be deemed adulterated, as well as conditions under which FDA may find delays, denials, limits, or refusals to be reasonable actions of the owner.

Below are circumstances described in FDA’s guidance.  The circumstances listed in the guidance are not meant to represent all possible scenarios, but rather commonly encountered ones.

What circumstances may lead to a drug being deemed adulterated?  

  • Refusing an FDA inspector entrance into a facility
  • Failure to agree to a proposed inspection date with no reasonable explanation
  • Trying to postpone a scheduled inspection date with no reasonable explanation
  • Denying an FDA inspector access to an operational area of a facility with no reasonable explanation
  • Leaving an FDA inspector in a conference room without access to necessary documentation or responsible individuals for an unreasonable period of time
  • Failing to provide requested files to FDA with no reasonable explanation, despite being given a reasonable timeframe
  • Disallowing an FDA inspector to begin the inspection upon arrival at the facility
  • Disallowing an FDA inspector to inspect a facility because certain staff members are not present, without a reasonable explanation
  • Falsely stating a facility does not manufacture, process, pack, or hold drugs
  • Sending staff home on the day FDA plans to inspect and stating the facility is not producing any product
  • Discontinuing manufacturing for the duration of an FDA inspection without reasonable explanation
  • Limiting FDA’s observation to only a portion of the manufacturing process, or only allowing FDA to observe the manufacturing process for an unreasonably short amount of time.
  • Requiring an FDA inspector to leave a facility before the inspection is finished
  • Resisting photography that an FDA inspector feels is necessary to effectively conduct the inspection
  • Refusing to allow an FDA inspector to review records that FDA has authority to inspect
  • Providing unreasonably redacted records to FDA
  • Refusing to allow an FDA inspector to collect samples
  • Failing to answer or respond to FDA’s calls

What circumstances will FDA potentially deem reasonable?

  • Delays due to local conditions, such as weather or security situations, holidays and other non-work days, and scheduled manufacturing campaigns
  • Delays due to the time it takes FDA to accommodate documented gowning requirements
  • Delays due to the time it takes to translate requested records into English
  • Delays due to FDA requesting records that are currently being used for a manufacturing operation
  • Delays due to the amount of time it takes to compile the requested records, within reason
  • Appropriate personnel are not immediately available to answer an FDA inspector’s questions at the beginning of an unannounced inspection
  • A facility is closed due to scheduled maintenance when FDA arrives for an unannounced inspection
  • Denying access to a particular part of a facility because the inspector has not  completed training required by the Occupational Safety and Health Administration
  • Disallowing FDA to photograph products of which the product quality would be adversely affected by photography

Registrar Corp assists drug companies with FDA regulations.  We can provide further guidance in regards to FDA facility inspections, as well as register a drug firm and list its products with FDA, review and modify drug product labels for FDA compliance, assist with detentions, and more.  For questions about FDA facility inspections or other FDA drug regulations, contact Registrar Corp at 1-757-224-0177 or speak to a Regulatory Advisor 24 hours a day at


FDA Deleting Duplicate Food Facility Registrations

October 23, 2014 by David Lennarz

The U.S. Food and Drug Administration (FDA) is currently in the process of removing duplicate food facility registrations from its system.  Though the registration system will technically allow a facility to register multiple times, FDA only allows facilities to maintain one registration.

Why is this important?

Duplicate registrations can lead to unexpected problems.  For one, if a facility has multiple registrations, FDA does not consider which registration is most recent or is currently being used by the facility when it decides which registration to delete.  FDA may delete the registration that the facility is currently listing on its entry documents, which may lead to shipments being detained or refused entry into the U.S. due to the facility not being registered with FDA.

Even if FDA does not delete a duplicate registration, it could still cause issues.  FDA requires that facilities update their registration information within 60 days of changes.  Failing to update required elements of an FDA registration is a prohibited act under 21 C.F.R. 1.241 of the Food, Drug, and Cosmetic Act.   If a facility has multiple registrations but only updates one, that leaves one registration non-compliant, and the facility will be responsible.

If you are unsure about whether you are registered with FDA, or whether you have duplicate registrations on file with FDA, contact Registrar Corp.  We will check your facility’s FDA registration status for you.  If you are not yet registered with FDA, Registrar Corp can assist with that as well.  We offer a registration service through which we will properly register your facility with FDA and issue you a certificate of registration to include within your shipments.

Though a facility need only register with FDA once, all registered facilities are required to renew their registrations between October 1 and December 31 of every even-numbered year.  You can contact Registrar Corp by phone at 1-757-224-0177 or online through our 24 hour Live Help service:


FDA Import Refusals: Top 5 Labeling Violations

October 22, 2014 by David Lennarz

Labeling violations are one of the leading causes of food import refusals to the United States by the U.S. Food and Drug Administration (FDA).  According to OASIS, FDA’s import refusal database, FDA has identified approximately 5,029 labeling violations on products being offered for import so far in 2014 alone.  Registrar Corp has compiled a list of the five most commonly committed labeling violations.

1. “The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.”

Over a thousand import refusals in 2014 have been fully or partially due to missing nutritional information.  FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel.  The nutrition facts panel displays information such as a serving size, the number of calories the product contains, and the percentage of your suggested daily fat intake it contains. FDA takes nutrition labeling very seriously.  There is even an import alert regarding nutritional labeling violations.  If a product is found to be in violation of certain nutritional labeling requirements, it is noted in FDA’s PREDICT system.  If the same product is found to be in violation again 60 or more days after the initial violation, that product will be added to the import alert and be subject to detention without physical examination (DWPE)

2. “It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.”

FDA requires that every ingredient contained within a food or beverage be disclosed on the label in descending order of the prominence of the ingredient.  However, FDA does not require you to reveal the exact formulation as that may be considered a trade secret.

3. “Required label or labeling appears to not be in English per 21 CFR 101.15(c)”

FDA requires that all words, statements, and other information on labels appear in English.  A label may include other languages along with English, but if a foreign language is used anywhere on the label, all of the information on the label must appear in that language as well.

4. “The food is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regulations.”

FDA requires that a net quantity statement (a statement that provides the amount of food in a container or package) appears on the bottom 30% of the principal display panel (PDP) of a food label. The net quantity statement should only take into account the food, not the weight of the container, the packaging materials, etc.  The minimum type size for the net quantity statement depends on the size of the PDP.

5. “The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.”

FDA requires that the name and address of the manufacturer, packer, or distributor be listed on a food label.  Unless the listed name is the manufacturer, the label must also state the firm’s relationship to the product (“manufactured for”, “distributed by”, etc.). The address must include the city, state, zip code, and if the firm’s address is not listed in the current city directory or phone book, the street address.  The name and address are generally required to be placed together on the label.

If FDA discovers that your product has one of these five violations or any of the other 70 FDA labeling violations, FDA will consider the product to be “misbranded” and may refuse your product entry into the United States.  It is a prohibited act to distribute a misbranded product in the U.S. under the Food, Drug, and Cosmetic Act, and FDA can bring a civil or criminal action against a person who commits a prohibited act.

Along with checking at ports of entry, FDA will examine product labels during routine facility inspections.  The Food Safety Modernization Act (FSMA) mandated that FDA increase the number of foreign inspections it conducts each year.  By 2016, all facilities distributing products in the U.S. can expect to be inspected every 3 to 5 years, with high risk facilities being inspected most frequently.   If FDA finds a non-compliant label during an inspection, not only will the agency deem the product misbranded, but they also may decide to reinspect your facility at a later date to ensure the labels have been brought into compliance. If so, FDA will charge $217 USD per hour for reinspections of domestic facilities and $305 USD per hour for reinspections of foreign facilities.

Registrar Corp can help assure that your product labels are FDA compliant through our label review service.  Our Regulatory Specialists will cross reference your food labeling against thousands of pages in the Code of Federal Regulations and will return to you a modified, print-ready label, along with a detailed report explaining the recommended changes.  Additional reviews of the same label within 90 days of the initial report are offered free of charge.

For more information about FDA food and beverage label regulations, contact Registrar Corp at +1-757-224-0177 or receive online Live Help from a Regulatory Advisor:


FDA to Launch New Office of Pharmaceutical Quality

October 20, 2014 by David Lennarz

The U.S. Food and Drug Administration (FDA) plans to launch a new office in 2015.  This new Office of Pharmaceutical Quality (OPQ) will be dedicated to ensuring that quality medicines are available to U.S. citizens.  According to the OPQ webpage, OPQ will create a uniform drug quality program across all domestic and foreign sites of manufacture and across all drug product areas.

OPQ was proposed in September 2012 by Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research (CDER), who will serve as the acting director of OPQ.  In a statement to CDER staff, Woodcock said the new office would help “provide better alignment among all drug quality functions at CDER, including review, inspection, and research.”

Woodcock will be joined in leadership by Deputy Director Lawrence Yu, and many others from currently existing FDA offices:

  • Office of Program and Regulatory Operations (OPRO): Giuseppe Randazzo (Acting)
  • Office of Policy for Pharmaceutical Quality (OPPQ): Ashley Boam (Acting)
  • Office of Biotechnology Products (OBP): Director: Steve Kozlowski
  • Office of New Drug Products (ONDP): Sarah Pope Miksinski (Acting)
  • Office of Lifecycle Drug Products (OLDP): Susan Rosencrance (Acting)
  • Office of Testing and Research (OTR): Lucinda (Cindy) Buhse (Acting)
  • Office of Process and Facilities (OPF): Christine Moore (Acting)
  • Office of Surveillance (OS): Theresa Mullin (Acting)

Registrar Corp, an FDA compliance firm, stays up to date on FDA news and will keep readers posted as the new OPQ office unfolds.  Should you need any assistance with registering, listing, or labeling drug products, Registrar Corp can help.  Contact us at 1-757-224-0177 or receive Live Help from our regulatory specialists:


Registrar Corp Exhibiting at SIAL Paris 2014

October 17, 2014 by David Lennarz

Next week, Registrar Corp is heading to Paris, France for SIAL, the world’s largest food innovation marketplace.  Taking place from October 19 to 23, SIAL 2014 will host 6,300 exhibitors from 105 countries around the world.  Along with visiting exhibits, SIAL attendees can head to the SIAL Innovation Observatory to discover award-winning products and learn about the latest trends in the food market.

Need to know if your innovative new products meet U.S. Food and Drug Administration (FDA) regulations?  Still need to renew your FDA registration for FY 2015? Registrar Corp can help.  Stop by Registrar Corp’s SIAL exhibit stand 087 (Hall 4, U.S. Pavilion) for answers to all your FDA-regulation related questions.  You can also schedule a time to meet with us at the show.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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