FDA 483 - Arnold Professional Pharmacy - May 06, 2016

This FDA Form 483 documents observations made during an inspection of Arnold Professional Pharmacy, a producer of non-sterile drugs, located at 1460 Ritchie Highway, Suite 103, Arnold, MD 21012. The inspection was conducted on May 2, 4, and 6, 2016, and the report was issued to Neil P. McGarvey, Owner and Pharmacist.

Four observations were noted: 1. The firm does not perform appropriate laboratory testing of non-sterile drug batches for conformance to final specifications, identity, and strength of active ingredients prior to release. 2. Records of calibration checks for automatic, mechanical, or electronic equipment (e.g., balances, machines, thermometers) are not maintained. Specifically, there is no calibration record for thermometers used in the refrigerator storing compounded Lansoprazole 15 mg/5 ml. 3. The firm accepts component supplier Certificates of Analysis without performing at least one specific identity test on each component or validating the supplier's analyses. 4. Control procedures are not established to validate manufacturing processes that may cause variability in in-process material and drug product characteristics. The firm does not consistently perform in-process checks on produced non-sterile drugs.