enforcement

Brookfield Medical Cited on Repeated Potency Failures

FDA has cited Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification (OOS) potency results, finding that the company repeatedly attributed the failures to its contract testing laboratory and released most of the affected compounded drugs after retesting.

The findings were detailed in a recent Form 483 issued following a July inspection of the firm’s outsourcing facility. FDA listed three observations covering OOS investigations, quality-unit oversight and microbiological controls.

According to the inspection form, Brookfield recorded 13 potency OOS deviations between 2024 and 2026 involving four sterile drug products: triamcinolone acetonide, betamethasone sodium phosphate, methylprednisolone acetate and morphine sulfate. FDA said the recurring failures indicated a “systemic failure to maintain adequate process controls.” Twelve of the 13 OOS results were invalidated and the products released without documented evidence that Brookfield's quality unit independently reviewed the contract laboratory's raw data, chromatograms, instrument logs or reasons for invalidating the original results.

One betamethasone batch was released even though the contract laboratory said the root cause of its OOS result was undetermined. FDA said Brookfield conducted no further investigation or corrective and preventive action.

Investigators also questioned the speed with which several OOS investigations were closed. Four deviations were closed within five to seven days, a timeframe FDA described as “extremely compressed” for investigations involving both laboratory and manufacturing reviews. The agency also noted that Brookfield had not audited the contract laboratory during the period in which the 13 OOS results occurred.

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Gupta Raises Concerns About Overton’s Independence, Ideology

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