Refusal of Inspection : More Details
FDA Inspection / FDA Audit
FDA Inspection / FDA Audit: In order to determine compliance with applicable legislation and regulations, such as the Food, Drugs and Cosmetic Act and related laws, the Food and Drug Administration conducts inspections and assessments of regulated facilities.
Types of FDA Inspection
1. Pre-approval inspections for first-time product applications
- Abbreviated new drug application(Human / Animal) (ANDA / ANADA) and New drug application (Human / Animal) (NDA/NADA)
- Biologic license application (BLA)
- Medical Device Premarket Approval (PMA) application
2. Product-specific, post-approval inspections
Usually, this type of Inspection for Medical Device manufacturers.
3. Systems-based, routine inspections
Routine FDA inspection readiness is required for all facilities, regardless of product type or location.
Routine inspections, also known as surveillance inspections, take place every two years on average. Every two years, the FDA is required by law to inspect Class II and Class III medical devices.
4. For-cause inspections following a violation
For cause, inspections are conducted by the FDA to investigate prior violations and/or allegations.
- The findings of a sample analysis
- Observations from previous inspections
- Recalls of products or their removal from the market
- Complaints from customers or employees
- Reports of negative reactions
- Suspicion of deception
FDA Pre- Inspection Support Service
One of the most important activities is developing a GMP audit checklist covering all sections in relevant QSR. However, creating an audit checklist is not a simple task. It can take a long time to create, implement, and maintain a detailed checklist. And the consequences of failing to meet a checklist requirement can be severe. You risk failing your next FDA inspection and facing serious regulatory repercussions in the future.
A third party auditor with experience in each of these industries can assist you in Implementation check and GAP assessment, and GAP Fixing.
FDA Post- Inspection Support Service
The recipient of 483 should, though not legally required, answer the FDA in writing within 15 working days in order to avoid additional notice. If the company fails to respond to the 483, the FDA almost always issues a warning letter. An expert in this field can be a guide in analyzing each observation and draft later accordingly.
When serious violations are discovered and/or the firm’s response to the 483 is inadequate, the FDA issues a warning letter. We support manufacturers who avoid getting warning letters. The company has 15 days to respond to the warning letter with a possible action plan with a tentative date for closing.
A warning letter can lead to further regulatory action, such as import alerts, product seizures, and injunctions. In addition, for consumer protection, the FDA publishes both form 483s and warning letters on their website.
Contact us to know more about our services for total implementation in case of 510k application
Fees
Below explained the fees.
Our GMP Auditors are based in Chicago, Dusseldorf & Bangalore.
| Industry | Service Fees | Onsite Visit Charges | Travelling & Accommodation |
| Medical Device | $300 / Observation | $600 / Man-day | Actuals |
| Nutraceutical | $400 / Observation | $600 / Man-day | Actuals |
| OTC Drugs | $500 / Observation | $600 / Man-day | Actuals |
| API | $500 / Observation | $600 / Man-day | Actuals |
Form 483
If violations are discovered during the inspection, FDA inspectors will send a Form 483 to the factory at the closing meeting.
A list of findings made during the inspection can be found on form 483. At the closing conference, the inspector will consult and describe these findings to the supplier. A form 483, on the other hand, does not imply that the FDA has made a final decision about the facility’s GMP compliance.
Within 30 days of the inspection, the FDA will issue an Establishment Inspection Report (EIR). The FDA’s official assessment of a factory’s GMP compliance is reflected in the EIR.
Depending on the issues discovered during the inspection, the factory may be required to take additional action:
- If no violations were observed, no action was taken.
- When violations are discovered, but the issues do not warrant further regulatory action, voluntary action is suggested. In this case, improving GMP compliance is entirely optional.
- If violations discovered on-site necessitate additional administrative sanctions and mandatory corrective actions, official action will be taken.
Core Section covered in an FDA Inspection
- Organization and personnel
- Buildings and facilities
- Equipment and utensils
- Production and process controls
- Packaging and labeling
- Warehousing, storage and distribution
- Document and records controls
Our Services
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