FDA 483 - Custom Meds, Inc. - March 25, 2016

On March 25, 2016, the FDA issued a Form 483 to Custom Meds, Inc., a non-sterile compounding pharmacy located at 102 E Highland Blvd, Inverness, FL 34452-4847. The inspection, conducted from March 22-25, 2016, identified three observations.

Firstly, the firm was cited for not performing appropriate laboratory testing, including identity and strength of active ingredients, on finished drug products prior to distribution. The owner, Jessica E. Dileo, stated that no testing was conducted on non-sterile drug products distributed since December 22, 2015, for potency (topical and capsule products) or microbial limits (topical products). Examples included creams/gels with testosterone, estradiol, lidocaine HCl, and pentoxifylline, and capsules with progesterone and liothyronine sodium (T3).

Secondly, the firm lacked scientifically sound and appropriate specifications for drug products. Specifically, there were no established specifications for microbial limits for non-sterile topical drug products.

Thirdly, the firm failed to test each batch of drug product required to be free of objectionable microorganisms. Non-sterile topical preparations were not tested for the presence of objectionable microorganisms prior to distribution.