When an FDA inspector appeared at our door unannounced this past April 2010 for a routine inspection, Particle Technology Labs' Quality Assurance Coordinator Pailin Morales was happy to answer.  Since its launch in 1992, PTL has undegone many regular inspections, which have resulted in successful audits.  2010 was no exception.

"Every business handling food and drug material is subject to inspections," said Pailin.  "They look for noncompliance with 21CFR Parts 11, 210 and 211 regulations."

These regulations standardize the practices allowed for manufacturing, processing or holding of drug and food materials.  Called cGMP, or current Good Manufacturing Practices, the federal regulations are essential to ensure the overall health and safety of the public.  

Labs are busy places.  Keeping quality standards where they belong is a constant challenge. PTL's Quality Assurance Unit is driven to not just maintain its present quality system, but to consistently look for ways to improve existing policies and practices at the same time.  It is by this strong standard that we can proudly assert that PTL has not incurred any FDA form-483 reports to date.

“We strive really hard to work with the FDA during their inspections of our facility,” said Pailin.  “Through our efforts and abilities, we’ve steadily demonstrated a reliable quality system.  When the FDA recommends an improvement, we make the resources available so that it can be implemented as soon as reasonably possible.” 

We anticipate nothing less than another successful inspection in 2011.