FDA 483 - National Prescription Services Inc. dba HRI Pharmacy - November 24, 2014

This FDA Form 483, issued to National Prescription Services Inc. dba HRI Pharmacy, a producer of non-sterile drugs located in Warrenville, IL, details observations from an inspection conducted between November 12 and November 24, 2014. Kenneth M. Behr, Pharmacist and Owner, was the recipient.

Five observations were noted: 1. **Equipment and utensil cleaning:** The firm lacks evidence that its cleaning procedure for b(4) product contact surfaces sufficiently prevents cross-contamination, specifically for the b(4) between capsule batches and the b(4) before replacement b(4). This impacts products like Nystatin, Metronidazole, vitamins, minerals, and amino acids. 2. **Control procedures for manufacturing processes:** The firm has no data to support the adequacy of its b(4) blending process for encapsulated drug products or data on the particle sizes of powdered drug components, including Nystatin and Metronidazole. 3. **Drug product testing and release:** The firm does not chemically test its drug products, including Nystatin capsules and oral suspension, Metronidazole capsules and oral suspension, and Naltrexone topical cream, for identity and strength prior to release. 4. **Stability testing program:** There is no written testing program or stability data to support assigned expiration periods for drug products such as Naltrexone 6mg/ml Cream Safflower (6 months