Burklow Pharmacy – FDA 483, Mar 4, 2015

This FDA Form 483 was issued to Stephen A. Burklow, Owner and Pharmacist of Burklow Pharmacy, Inc., located at 4880 Woodbine Rd, Pace, FL 32571. The firm is identified as a producer of non-sterile drug products. The inspection was conducted from March 2, 2015, to March 4, 2015, by Investigator Michael H. Tollon.

Three observations were noted: 1. Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, the firm does not test non-sterile drug products for objectionable microorganisms prior to distribution. 2. Laboratory controls do not include the establishment of scientifically sound and appropriate specifications to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Specifically, there are no established specifications for microbial limits for the non-sterile drug products prepared by the firm. 3. Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to final specifications and identity and strength of each active ingredient prior to release. Specifically, the firm does not test each batch of finished drug product prior to distribution. For example, for the last three months, non-sterile drug products like progesterone creams, testosterone capsules, and buprenorphine troches were prepared and distributed without potency testing.