FDA 483 - Lloyd Inc. of Iowa - September 15, 2023

On September 11-15, 2023, FDA investigators Soyinka S. Eneng and Michele Perry-Williams inspected Lloyd Inc., of Iowa, a manufacturer of human and animal drugs and animal food products located at 604 W Thomas Ave, Shenandoah, IA. The inspection revealed seven observations.

Observation 1 noted that buildings used for holding drug products were not maintained in good repair. Specific issues included residue on laboratory walls, rust on a sink near the (b)(4) Processing area, rust stains on a ceiling pipe above the (b)(4) Processing area, and numerous holes/openings around dock doors in both the manufacturing/packaging and warehouse facilities, as well as holes in the ceiling over label/labels used during packaging.

Observation 2 indicated that procedures to prevent objectionable microorganisms in non-sterile drug products were not established, specifically lacking microbiological testing for Burkholderia Cepacia Complex in USP water used for cleaning processing equipment.

Observation 3 stated that laboratory records lacked complete documentation of testing and standardization of reference standards and solutions. Analytical work under Protocols VAP-02-2015 and VAP-04-2016 was not fully validated or documented in a validation report, and CAPA Effectiveness Check No. EC-001-2020 lacked a target completion date.

Observation 4 found that responsibilities and procedures for the quality control unit were not in writing. Supplier