Bright Plastics Receives FDA Approval of Cleanroom Facility
Bright Plastics, Inc. - a custom injection molding company - has received the Food and Drug Administration's (FDA) approval for its cleanroom operations.
Bright Plastics maintains an ISO 7, Class 100,000 cleanroom in which various products are produced for the medical industry in a carefully controlled environment. The FDA inspected the operations and has deemed them safe and acceptable for all approved uses, specifications and restrictions.
VP of manufacturing for Bright Plastics, Todd Poteat said, "We diligently follow the rules as outlined by the FDA, as well as adhere to ISO quality management standards. Bright Plastics will continue to work alongside our customers to provide safe, quality products to the medical industry."
The FDA is responsible for protecting the public health by insisting upon compliance to their regulated guidelines established for medical devices, drugs, food supply, cosmetics, etc.
- ISO 9001:2015 Certified - ISO 13485:2016 Certified
- FDA Registered – For our ISO 7 (Class 100,000) cleanroom
- UL Certified
- First Article Inspections (FAI), Production Parts Approval Process
(PPAP), and statistical analyses are performed consistently.
- Production Part Approval Process (PPAP) according to Automotive Industry Action Group (AIAG) standards.