Pine Lake Investments, Inc. – FDA EIR, Mar 18, 2021

A routine Good Manufacturing Practice (GMP) surveillance inspection of Pine Lake Investments, Inc. DBA Pine Lake Laboratories in Bristol, CT, was conducted from March 17-18, 2021. This inspection, carried out under the New Inspection Protocol Project and CPGM 7356.002, primarily focused on the company's Quality and Laboratory systems and followed up on a prior records request. The inspection confirmed that all three observations from a previous 2016 FDA inspection had been satisfactorily corrected.

During the two-day inspection, FDA investigators raised two key concerns with company management, though these did not result in a formal FDA-483 observation. The first issue involved inadequate controls over the firm's data acquisition software, as a Group Leader performing sample testing also held administrative privileges for the HPLC software. This raised questions regarding data integrity and proper separation of duties. The second concern was the absence of use logs for temperature-controlled storage units. This deficiency was highlighted by a past power outage that caused refrigerated samples to be stored outside their required temperature ranges for extended periods, impeding the ability to thoroughly investigate such incidents without detailed documentation. Company management acknowledged both concerns. No samples were collected, and the inspection was completed without any refusals.