FDA EIR - Dynalabs LLC - September 13, 2013

An FDA inspection of DYNALABS LLC, a contract testing laboratory for compounded finished-dose pharmaceutical products in Saint Louis, MO, was conducted from September 9 to September 26, 2019. This inspection, carried out under the regulatory framework of CP 7346.832, "Drug Manufacturing Inspections," covered all aspects of the analytical and microbiological laboratory operations. At the conclusion of the inspection, a four-item FDA Form 483, detailing inspectional observations, was issued. The main deficiencies included the company's failure to establish accurate, specific, and reproducible test methods, and a similar failure to use reliable and meaningful test methods for stability-indicating claims. Furthermore, DYNALABS LLC was cited for not adequately recording and justifying deviations from established specifications, standards, test procedures, and laboratory mechanisms. A significant issue also involved the quality control unit's failure to fully document and adhere to its responsibilities and procedures. Additionally, an inconsistency was noted in the firm's policy on Quality Agreements, as only about 30% of their 503B customers had signed agreements despite the stated requirement for all clients. The company stated its intention to provide a written response to the FDA Division within 15 business days addressing these observations.