FDA WARNING_LETTER - Adamson Analytical Laboratories, Inc. - March 23, 2021

The FDA inspected Adamson Analytical Laboratories, Inc. from March 8-23, 2021, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drugs adulterated. The firm, a contract testing laboratory for prescription and over-the-counter drug products and APIs, received an inadequate response to their Form FDA 483.

Key violations include: 1. **Inadequate Computer System Controls (21 CFR 211.68(b)):** Laboratory personnel had administrative privileges on Gas Chromatography (GC) data acquisition systems, allowing data deletion/alteration. High-Performance Liquid Chromatography (HPLC) and GC instruments operated without activated audit trails from April 2018 to February 2021. Electronic microbial challenge efficacy testing worksheets used unvalidated formulas, generating erroneous data. This is a repeat violation from a 2016 warning letter. 2. **Failure to Establish Laboratory Control Mechanisms (21 CFR 211.160(a)):** Critical changes to electronic laboratory monitoring, such as implementing electronic worksheets and activating instrument software audit trails, occurred without Quality Unit (QU) oversight or proper change control.

The FDA recommends retaining a qualified consultant for data integrity remediation and CGMP compliance, emphasizing that the firm's executive management remains responsible. The firm must provide a comprehensive investigation into data inaccuracies, a risk assessment, and a management strategy with a global