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

Source: https://www.keypedia.com/records/483/ideal-specialty-apothecary-inc-dba-ideal-pharmacy/5ba8469b-9697-4d08-bee1-b4ff131538e3

> FDA 483 for Ideal Specialty Apothecary Inc., dba Ideal Pharmacy on August 31, 2017. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ideal Specialty Apothecary Inc., dba Ideal Pharmacy
- Inspection Date: 2017-08-31
- Product Type: Drugs
- Summary: 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

## Related Officers

- [Team Lead, Office of Compounding Quality and Compliance, OC, CDER](https://www.keypedia.com/people/neda-hamandi/01eca5d6-e9cc-40ab-a1da-00d9d228e4dc)
- [ Investigator ](https://www.keypedia.com/people/zakaria-i-ganiyu/59c3a596-f3fc-43d9-9fa9-b763aec375d1)
- [Zakaria Ganiru](https://www.keypedia.com/people/zakaria-ganiru/89fe3897-3471-4337-be75-eae1979a20f1)
- [Compliance Officer at FDA](https://www.keypedia.com/people/emmanuel-j-ramos/ba0666bd-2752-453e-9fd3-5e43b1cff3ad)
- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.keypedia.com/companies/ideal-specialty-apothecary-inc-dba-ideal-pharmacy/e9fe1c1c-0470-4a98-9272-1ff89ef4dd11