FDA 483 - coast quality pharmacy, llc - May 07, 2018

The FDA Form 483 details numerous violations at a facility producing radiopharmaceuticals like In-111-DTPA. A critical finding is the use of non-pharmaceutical grade In-111 and DTPA, lacking testing for microorganisms and endotoxins. The facility also fails to test In-111 for chemical impurities, radiochemical purity, radionuclide purity, microorganisms, yeasts, mold, and endotoxins.

Significant quality system and manufacturing issues include poor aseptic techniques: returning withdrawn material to stock vials, using non-sterile wipes in ISO 5 areas, and improper disinfection of equipment. Environmental monitoring revealed objectionable organisms (Coagulase-negative Staphylococcus, fungi, Bacillus spp.) in ISO 7 and ISO 8 rooms without documented corrective actions. Smoke studies under dynamic conditions are lacking, and unidirectional laminar airflow is not demonstrated.

The facility uses non-representative samples for endotoxin testing (syringe rinses instead of finished product). Equipment like lyophilizers are not validated, leading to product being stuck in cycles. De-crimped, commercially sterile vials are stored improperly in ISO 7 conditions without documentation of storage time.

Repeated deficiencies from a previous inspection include: - Lack of daily surface and air monitoring in ISO-5 LAFWs. - No daily personnel monitoring (fingertip sampling). - Unassessed suitability and efficacy of disinfecting agents. - Lack of written procedures for component receipt, identification, storage, handling, sampling, testing