FDA EIR - Chartwell Pharmaceuticals Carmel LLC - December 16, 2019

During an FDA inspection conducted at Lannett Company, Inc.'s Carmel, NY facility from December 3 to December 16, 2019, several significant deficiencies related to Good Manufacturing Practices (GMP) were observed. The inspection, which also included a pre-approval assessment for ANDA 213110 (Clobazam Oral Suspension), resulted in an FDA Form 483 citing three main issues. Firstly, the company's written procedures for cleaning and maintenance were found to lack sufficient detail regarding methods, equipment, materials, and equipment disassembly, impacting the repeatability and assurance of proper cleaning. Furthermore, cleaning validation protocols and swab recovery studies for product-contact parts were inadequate. Secondly, routine inspection and checking of automatic, mechanical, and electronic equipment, particularly the filling equipment and mixers, were not performed according to a written program designed to assure proper performance or qualified at their intended operating ranges. Lastly, the firm failed to submit NDA-Field Alert Reports within the required three working days for two distributed drug products (Hydroxyzine Hydrochloride Oral Solution and Haloperidol Oral Solution) that exhibited out-of-specification stability results. These observations indicated non-compliance with regulatory frameworks such as 21 CFR 211.67(b), 21 CFR 211.68(a), and 21 CFR 314.81(b)(1)(ii). Lannett management committed to providing a written response to the FDA 483 within 15 business days. Notably, corrections from a previous inspection regarding complaint handling and temperature monitoring were verified as resolved. The pre-approval inspection for Clobazam Oral Suspension received an "Acceptable" recommendation.