FDA QSR Inspection

FDA Inspection & Audit. If your firm registered with FDA under any regulation as a manufacturer/trader/ distributor for any FDA regulated products, sooner or later, you could expect an inspection from the FDA sooner or later. FDA inspection is conducted worldwide registered facilities to verify compliance with all relevant regulations.

FDA inspection / Audits are mainly classified into four types based on activities carried out in the below sectors:

    • Pharmaceutical / Drug manufacturers
    • Medical Device manufacturers
    • Blood banks
    • Nutraceutical / Food Supplement and or Food processing facilities
    • Dairy farms
    • Animal feed processors
    • FDA approved Compounding pharmacies
    • Clinical trial organizations.
    • Pre- Clinical laboratories conduct studies in animals for the medical device product

Types of FDA Inspection & Audit

FDA intends to protect the public from unsafe products; the below four different types of inspection conducted

The type of inspection conducted after a company submits an application to the FDA to market a new product.
The type of inspection are mandated by law every 2 years once (for class II and class III medical device manufacturers, nutraceutical, cosmetic, food and drug manufacturers).

The type of inspection conducted to review actions taken by a firm/manufacturer in response to a previous inspection that resulted in significant 483 observations or a Warning Letter.

The type of inspection conducted to investigate a specific problem that has been reported to FDA. The source of the report can be from the manufacturer or consumer or user, or even an employee in the same company.

Each FDA Inspection/Audit is intended to help protect the public from unsafe products, but the focus and expectations of each type of inspection are different.

Our services are designed to provide efficient technical support intended to help manufactures to reduce the findings/observations identified by FDA inspectors.

We have customized expert technical services to suit client requirements covering Food, Medical devices, Pharmaceuticals across the globe from our office locations in the USA, INDIA & GERMANY.

21 CFR Part 111 / 110

GMP Requirements for  Dietary Supplement Manufactures

Code of Federal Regulations 21 CFR Part 110 requirements for Current food good manufacturing practices (GMPs) describe the methods, equipment, facilities, and controls for producing processed food.  The minimum sanitary and processing requirements for making safe and wholesome food are an essential part of regulatory control over the nation’s food supply safety.

FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering “conventional” foods and drug products. Code of Federal Regulations 21 CFR Part 111 all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with testing, quality control, and distribution, must comply with the above rule for Dietary Supplement Current Good Manufacturing Practices if marketed in the US.

Post-2016 FDA is more serious and alert on CGMP regulations on nutraceutical/food supplements. If you are a small or large dietary supplement manufacturer, you need to strictly comply with FDA 21 CFR part 111 regulation and be ready to face FDA inspection. The I3CGlobal team is large enough to provide high-quality technical expertise and deliverables in the following areas.

  • US FDA 21 CFR Part 110 and 21 CFR 111 Guidance and Compliance consulting on Facility, Infrastructure, Manufacturing, Quality Control & Documentation.
  • US FDA 21 CFR Part 111 FDA Pre Inspection / Audit.
  • US FDA 21 CFR Part 111 Post Inspection 483 Response preparation and submission.

21 CFR 111 – Our Fees

Option 01 GMP Implementation Service Would you mind writing to us
Option 02 FDA Pre Inspection GAP Analysis with Report (No Guidance included) 500 USD/man-day
Option 03 Closing of 483’s 500 USD /483

Note: Option 02 Consultants will be traveling from the nearest office location [Chicago, Cologne,  Bangalore],  Travelling and Lodging additional

21 CFR Part 211

GMP for Finished Pharmaceuticals

FDA inspects registered drug manufactured facilities. In comparison to previous years, the number of facilities has increased by 20%. FDA inspectors demand complete adherence to GMP requirements outlined in 21 CFR part 211. Anything less than total adherence will earn the manufacturer the FDA’s stamp of “adulterated” or “misbranded.” Failure to comply could result in a company facing disruptive regulatory action. Many manufacturers who have registered with the FDA are unaware of the extent to which compliance is required.

21 CFR Part 210 outlines minimum Good Manufacturing Practices (GMP) in the manufacturing, processing, packing, or holding of all types of drugs subject to FDA scrutiny. In contrast, 21 CFR Part 211 focuses on the GMP requirements for finished pharmaceuticals.

Manufacturers have a hard time correctly interpreting how each clause must be met, according to FDA inspectors. Whether intentional or not, this ambiguity exists between what FDA inspectors will enforce in terms of GMP compliance and what it simply recommends or desires. This level of uncertainty necessitates the involvement of knowledgeable and experienced hands in guiding and interpreting standards and the decision-making process regarding compliance issues.

I3CGlobal hardcore regulatory professionals have between 12 and 22 years of international experience in US FDA 21 CFR 211 compliance consulting for OTC and generic drugs. The following is part of our compliance service:

Type of Services we offer

  • US FDA 21 CFR 211 Pre Inspection / Audit.
  • US FDA 21 CFR 211 Post Inspection Consultation.
  • US FDA 21 CFR 211 Post Inspection 483 Response preparation and submission.
  • US FDA 21 CFR 211 483 Response, Guidance on closing CAPA and Follow up with FDA.

For pricing, refer to the last section of the menu.

Refer 21 CFR part 211 and 210 standard 

21 CFR Part 820

The US FDA’s current good manufacturing practice (CGMP) requirements for medical devices are found in Title 21 Part 820 of the Code of Federal Regulations. In short, FDA 21 CFR Part 820, also known as the Quality System Regulation QSR, outlines Current Good Manufacturing Practice (CGMP) regulations that govern the methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished medical devices intended for human use and sale in the United States of America.

Medical devices must meet these requirements to be safe and effective. FDA inspections of medical device manufacturers are conducted randomly to ensure QSR FDA 21 CFR 820 compliance. Hiring 21 CFR part 820 Consultants is highly recommended, especially for foreign manufactures and exporters. There is no Certification for 21 CFR 820; FDA does not require certification; only compliance with the standards is recommended.  FDA might come for an inspection of your facility at some point where your organization is registered and products are listed and available in the US Market. In effect is a “certification” if you pass.

We provide the following services related to Medical Device GMP ( 21 CFR part 820).

  • Implementation support
  • External GAP analysis and Audit
  • FDA pre-inspection audit
  • FDA Post inspection support for closing non-conformities (FDA 483)

Refer to our pricing in the next section.

FDA 483  / FDA Warning Letter

The FDA form 483 is officially called a Notice of Inspectional Observations, commonly referred to as an FDA 483. An FDA 483 is issued to an organization by the FDA investigator(s) for violations against GMP regulation/quality system or conditions that violate the Food, Drug, or Cosmetic Act. This is applicable to food, drug, device, or cosmetics.

Organizations are encouraged to respond to the FDA 483 warning Letter(s) for each inspectional observation by writing CAPA signed by the respective initiator and department head with an action plan expeditiously in a specified timeframe. The quality and promptness of your response to this letter are paramount.

Our team can support organizations in preparing an effective response to an FDA 483 warning letter by understanding the actual situation for the cause of observation, analyzing the root cause, discuss with the process owner for the immediate corrective action.

As part of our services, we will:

    • Analyze the observation given to the manufacturer in US FDA 483 form.
    • Identify the root cause of the comment in consultation with the client team and process owner.
    • Support process owner to initiate CAPA (against FDA 483 warning letter).
    • Submit an initial response to FDA 483 warning letter with a possible timeline to close each FDA 483 / observation within 10 to 14 days.
    • Assist the organization in developing a roadmap, identifying responsible process owners, and guiding them on what to do.
    • Guide, review, correct, and modify evidence submitted by the client team against each respective CAPA.
    • Support in answering to US FDA during the submission of response and evidence.

It is critical for all those who received FDA 483s to be aware of the following information. The FDA’s fast handover of 483s puts pressure on manufacturers to respond within 15 days of the inspection’s conclusion. Manufacturers (recipients of FDA 483 warning letters) must understand that a non-technical response will result in a permanent warning and the possibility of further enforcement action, which will result in an additional inspection. An FDA 483 response s should include only practical corrective actions and timeframes. A CAPA with little thought and ineffective disciplinary action, as well as a realistic closing date. At this point, our services play an essential role.

GMP Service Fees

The following are the applicable fees for various regulations.

The timeline depends on various factors such as type of product, number of employees, number of products, manufacturing shop floor etc…

21 CFR Part 111

Option 01 GMP Implementation Service Would you mind writing to us
Option 02 FDA Pre Inspection GAP Analysis with Report (No Guidance included) 500 USD/man-day
Option 03 Closing of 483’s 400 USD /483

21 CFR Part 211

Option 01 GMP Implementation Service Would you please write to us
Option 02 FDA Pre Inspection GAP Analysis with Report (No Guidance included) 600 USD/man-day
Option 03 Closing of 483’s 500 USD /483

21 CFR Part 820

Option 01 GMP Implementation Service Would you please write to us
Option 02 FDA Pre Inspection GAP Analysis with Report (No Guidance included) 500 USD/man-day
Option 03 Closing of 483’s 400 USD /483

Note: Option 02 Consultants will be travelling from nearest office location [Chicago, Cologne,  London, Bangalore, ] Travelling and Lodging additional