Lato Drug Co. Inc. dba Post Haste Pharmacy – FDA 483, Feb 20, 2015

On February 20, 2015, the FDA issued a Form 483 to Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy, located at 4401 Sheridan St, Hollywood, FL 33021-3513, following an inspection conducted from February 12-20, 2015. The firm is a producer of non-sterile drug products.

The inspection revealed three observations:

1. **Observation 1:** The firm does not test each batch of drug product required to be free of objectionable microorganisms through appropriate laboratory testing. Specifically, non-sterile drug products are not tested for the presence of objectionable microorganisms prior to distribution. 2. **Observation 2:** Laboratory controls lack scientifically sound and appropriate specifications to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Specifically, there are no established specifications for microbial limits for the non-sterile drug products produced. 3. **Observation 3:** Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications and identity and strength of each active ingredient prior to release. For example, for the last three months, non-sterile drug products such as progesterone, testosterone, and Diazepam in various dosage forms (capsule, cream, gel, spray, tablet, suspension, suppository) were distributed without testing for potency and microbial