FDA 483 - Burt's Pharmacy, LLC - October 07, 2022

During an inspection from October 4-7, 2022, the FDA issued a Form 483 to Burt's Pharmacy, LLC, a producer of nonsterile drugs, citing significant deficiencies in its manufacturing processes. The observations indicate potential violations of the Federal Food, Drug, and Cosmetic Act, particularly concerning drug quality and control.Key issues included the use of non-pharmaceutical grade components in drug formulations, such as those for Meperidine HCl and Dyclonine HCl, without adequate assurance of their microbiological or chemical quality. The inspection also revealed widespread problems with cross-contamination prevention. This included finding loose powder and residue on 'clean' capsule equipment and inside supposedly clean hoods, along with the use of cleaning agents without proof of their effectiveness against hazardous compounds like hormones and potent drugs. Damaged equipment, such as spatulas and mixing containers with rough, non-cleanable surfaces, and even corroded cleaning brushes, further compromised product integrity.Furthermore, Burt's Pharmacy released a Liothyronine (T3) capsule lot despite potency test results indicating it failed to meet finished drug specifications, lacking scientific justification for its release. Finally, insanitary conditions were noted, including the presence of a live spider in the hazardous production room and an exterior door gap that could allow vermin entry. The firm is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance and drug safety.