FDA 483 - Ideal Specialty Apothecary Inc., dba Ideal Pharmacy - August 31, 2017

This FDA Form 483 was issued to Ideal Specialty Apothecary Inc., dba Ideal Pharmacy, located at 2333 Morris Ave, Suite B101, Union, NJ, a producer of sterile and non-sterile drug products. The inspection occurred on multiple dates between June 19, 2017, and August 31, 2017.

Six observations were noted:

1. **Inadequate ISO-5 Environment:** The ISO-5 aseptic filling area maintained a negative pressure gradient to the surrounding unclassified room, risking contamination from lower-quality air, especially when opened for cleaning. The system was not tested for leaks each time it was changed. This impacts sterile drug products like Medroxyprogesterone Acetate 150mg/mL Intramuscular Injection Suspension (MPA), with environmental viable particulate tests showing microbial contamination (Bacillus, Micrococcus, Staphylococcus Coagulase (-), fungi) in both the unclassified room and the ISO-5 area.

2. **Improper Cleaning Practices:** Non-sterile cleaning pads were used for initial cleaning inside the ISO-5 area and stored in an open package. Resealable pouches of pre-wetted sterile wipes were reused without an established expiration date after opening, compromising sterility assurance.

3. **Insufficient ISO-5 Certification:** The ISO-5 area was not certified under dynamic conditions representative of routine operations. Airflow smoke