mytillin enterprises llc – FDA 483, Aug 17, 2017

This FDA Form 483 document outlines several violations observed during an inspection of a drug product manufacturing facility.

**Facility and Operations:** The firm prepares and dispenses approximately 1,500 drug products monthly, including patient-specific and non-patient-specific items like Atropine 1% Oral Solution, Diazepam 10mg Suppositories, Phenobarbital 100mg Suppositories, and Lorazepam 1mg Suppositories. They also produce human drug products (hormones, antibiotics, controlled substances) and veterinarian drug products (cisapride, diethylstilbestrol, phenylpropanolamine) using non-dedicated equipment within two PowderSafe AirClean Systems Ductless Balance Enclosure hoods.

**Violations and Observations:**

1. **Lack of Final Product Testing:** Drug products were prepared and dispensed without testing for identity or potency, failing to ensure conformance to final specifications. 2. **Inadequate Equipment Cleaning and Maintenance:** * Lack of cleaning records for non-dedicated equipment and utensils used with potent drug substances. * No cleaning validation data for household dish soap and multipurpose cleaner used as cleaning agents. * Use of household dish soap, multipurpose cleaner, and tap water for cleaning, with no purified water final rinse or quality testing of tap water. Equipment is air-dried on a rack adjacent to the sink. * Use of reusable microfiber cloths and isopropyl alcohol