FDA WARNING_LETTER - Acella Pharmaceuticals, LLC - January 07, 2020

The FDA inspected Acella Pharmaceuticals, LLC (FEI 3006691461) from December 17, 2019, to January 7, 2020, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). This renders their drug product adulterated under section 501(a)(2)(B) of the FD&C Act. Additionally, NP Thyroid products are adulterated under section 501(b) for failing to conform to compendial standards for strength, quality, or purity. NP Thyroid products are also considered unapproved biological products.

Violations include: 1. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: Acella's active ingredient assay specifications for levothyroxine and liothyronine in NP Thyroid were (b)(4), while the USP monograph for Thyroid Tablets requires (b)(4). Although Acella updated specifications, an FDA inspection of their CMO (May 5-15, 2020) found 13 lots within expiry, made with a previous API supplier, that exceeded 110.0% USP specification during release or stability testing, which Acella subsequently recalled. 2. **Failure to establish an adequate quality control unit (21