The Compounding Pharmacy – FDA Warning Letter, Apr 8, 2019

The FDA issued a Warning Letter to The Compounding Pharmacy in Hickory, NC, following an inspection from March 18 to April 8, 2019. The inspection revealed the facility produced drug products failing to meet Section 503A of the FDCA exemptions and serious deficiencies in sterile drug product practices, posing patient risks.

Violations included compounding chloroform and nitrofurazone, substances on FDA's withdrawn/removed list (21 CFR §216.24), rendering these products ineligible for exemptions from CGMP, adequate labeling, and FDA approval. Consequently, these "ineligible drug products" are considered adulterated under Section 501(a)(2)(A) and misbranded under Section 502(f)(1) of the FDCA.

Specific insanitary conditions noted were: unverified materials for endotoxin contamination, a porous and hard-to-clean laminar flow hood surface, an unsealed ceiling tile with a cracked light cover in the cleanroom, and chipped paint around anteroom door frames.

The firm's April 16, 2019, response to the FDA 483 was deemed inadequate due to insufficient information or supporting documentation for proposed corrective actions, such as endotoxin testing procedures, hood surface remediation, and cleanroom repairs. The FDA acknowledged the firm's commitment to cease compounding chloroform and nitrofurazone. The FDA recommends a comprehensive assessment of operations, particularly aseptic