wood's pharmacy, inc., – FDA 483, Jan 15, 2015

The FDA Form 483 documents significant deficiencies in the facility's drug product manufacturing and quality control. A primary concern is the lack of analytical testing for finished product potency, meaning drug products like Methimazole, Testosterone, Biestrogen/Progesterone transdermal gels, Aspirin, and Ketoprofen capsules are released without laboratory confirmation of active ingredient identity and strength.

The firm also lacks a written stability testing program, resulting in unsupported expiration periods (e.g., 6 months) for the aforementioned products. Expired chemicals/components, including Magnesium Stearate NF, Glucosamine Hydrochloride USP, and Promethazine Hydrochloride USP, were found near the production area and used in products.

Laboratory controls are deficient, with no calibration records for the sole scale used for weighing chemicals. Furthermore, written procedures for cleaning and maintenance of equipment (e.g., mortar and pestle) are absent, and no documentation of cleaning exists.

Manufacturing process controls are inadequate, lacking weight checks for capsules and data to support homogenous blending of ingredients. There are no procedures or tests to ensure correct particle size, with employees relying on visual inspection for consistency and grinding. These observations indicate a failure to establish and follow appropriate quality system and manufacturing processes, potentially impacting drug product quality, safety, and efficacy.