FDA 483 - Rx Compounding Inc. - August 21, 2014

During an FDA inspection conducted on August 6, 8, and 21, 2014, several observations were made regarding the firm's sterile ophthalmic drug manufacturing operations.

Observation 1 notes the absence of sterility testing for batches of sterile processed ophthalmic drugs, citing examples such as Vancomycin 25 mg/mL (processed 5/5/2014) and Cyclosporin 1% Suspension (processed 6/19/2014).

Observation 2 highlights deficiencies in environmental monitoring within aseptic processing areas, specifically that environmental monitoring of the (b)(4) does not occur each time a sterile ophthalmic drug is formulated. Examples include Vancomycin 25 mg/mL (processed 7/10/2014) and EDTA 1% (processed 7/18/2014).

Observation 3 indicates that testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conformance to potency limits prior to release. Examples provided are Scopolamine 0.25% O.D. (processed 7/1/2014) and Tobramycin 14 mg/mL O.D. (processed 7/23/2014).

Observation 4 states that separate or defined areas to prevent contamination or mix-ups are deficient regarding aseptic processing operations, specifically that the (b)(