3 Types of FDA Inspections and What That Means for Medical Manufacturing Companies

Precision Plastic PartsMedical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in judgments and settlements collected in the fiscal year 2016.

The Food, Drug, and Cosmetic (FD&C) Act gave the FDA authority to conduct inspections at medical device manufacturing facilities. On a practical level, in general, the FDA’s inspection selection process is primarily driven based on risk. Those companies manufacturing higher risk devices, top the list. Thus, manufacturers of class III devices, newly registered facilities, implantable, life-supporting, and life-sustaining devices, are the primary subjects for inspection.

FDA uses the Quality System Inspection Technique (QSIT) for its inspections, a ‘top-down approach’ to inspecting a manufacturer’s QS. QSIT provides different inspectional levels based on the reason for the inspection. In the medical devices industry, QSIT is used by the FDA to assess the firm’s QS for compliance with the appropriate regulations and for inspection of domestic and foreign manufacturers of medical devices with the intention commercial distribution within the US.

Medical device companies will most likely face three types of inspections by FDA: a pre-approval inspection, a routine inspection, and a compliance follow-up inspection. The intention is to ensure and protect the public from unsafe products. The three are:

FDA Pre-Approval Inspections
Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection. A recommendation for approval is determined by inspectors following a site visit.

Rountine Inspections
By law, routine inspections take place every 2 years for class II and class III device manufacturers. Method of inspection follows the guidelines as outlined in the Quality System Inspection Technique (QSIT). Any violations or problems found during a routine inspection, the company would be subject to fines, or quite possibly temporary shutdown of production.

The Follow-Up Inspection
Compliance follow-up inspections are a response to warning letters or significant FDA Form 483 inspectional observations to verify that corrective measures have been taken by the manufacturer as a result of previous inspection violations. A compliance follow-up is conducted to document the correction of violation(s), or note continuing violations, or to take regulatory action.

Medical manufacturing companies can successfully and seamlessly bring compliant medical devices to market by following certain basic steps. Start by implementing a robust regulatory compliance program in-house. Prepare for FDA inspections. Your quality control program must help ensure, monitor and strengthen compliance across your company’s operations. Follow-up on previous inspections and document any corrective actions taken. Data is evidence, so maintain all records and documents. The key is to ensure compliance through documentation. Implement an effective, timely CAPA (Corrective and Preventive Actions) system to identify and address any violations immediately. Finally, make sure your company’s employees have a thorough awareness of FDA inspections and their compliance. You may even perform mock audits occasionally to prepare for inspections.

Reliable and Innovative Medical Manufacturing Companies That You Can Trust

It’s the medical manufacturer’s responsibility to keep abreast of the current FDA regulations as pertains to your company. Stay tuned in by attending conferences or webinars, review professional publications, and whenever there may be a question on compliance, ask for a ruling directly from the FDA.

Being subjected to government actions will consume time and resources for your company. Statutory and regulatory violations can result in injunctions, significant fines, unwanted publicity, even criminal penalties, or consumer and shareholder lawsuits. In this regard, the goal for all medical manufacturers is to maintain FDA awareness and make sure your company stays compliant.

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Plastic Products Catalog

BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

Non-Sterile and Sterile Centrifuge Bottles

  • Available with standard caps for low-speed work and sealing caps for high-speed applications
  • Caps have a built-in gripper to facilitate removal from the rotor
  • Extra thick walls for durability-resistant to most chemicals
  • Wide mouth design makes filling and decanting easier
These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity. Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity. Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure. Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.
centrifuge bottle
Sterile Centrifuge Bottles 
 
centrifuge bottle
Non-sterile Centrifuge Bottles

Cytology Funnels Category

BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


 

metal cytology funnel clip

Metal Cytology
Funnel Clips

Double Cytology Funnels

Double Cytology Funnels

Single Cytology Funnels

Single Cytology Funnels

Hemodrop Blood Dispenser

The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.  
hemodrop
Hemodrop

Multipurpose Containers

These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.


centrifuge
Translucent Multipurpose
Containers

Polypropylene Beakers

Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).
centrifuge
Polypropylene Beaker

Specimen Collection

For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit. 

centrifuge

Commode Specimen
Collection Systems

urine container

24 Hour Urine Containers

urine container

24 Hour Urine Containers with Spout

Tissue & Ultra Tissue Grinders

We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

tissue grinder

Tissue Grinders

ultra tissue grinder

Ultra Tissue
Grinders

Urine Sedimentation System

BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

 

Urine Sedimentation

Urine Sedimentation
System