FDA WARNING_LETTER - atlantic management resources ltd - August 10, 2022

The FDA issued Warning Letter #642082 to Atlantic Management Resources Ltd. dba. Claire Ellen Products, FEI 3014117482, following an inspection from July 26, 2022, to August 10, 2022. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Inadequate Quality Unit (21 CFR 211.22(a) and (d)):** The firm failed to establish a quality unit with written procedures for quality operations, including sampling, testing, supplier qualification, and release of finished products. 2. **Improper Storage Conditions (21 CFR 211.142(b)):** Drug products, containers, and closures were not stored under appropriate conditions (temperature, humidity, light), despite a bulk drug's sensitivity to heat, sunlight, and moisture. 3. **Lack of Batch Production and Control Records (21 CFR 211.188(b)):** The firm failed to maintain batch records or assign batch numbers, which are essential for documenting manufacturing operations.

Additionally, Atlantic Management Resources LTD distributed unlisted drug products (e.g., Neuroquell Plus Cream), violating drug