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# FDA Finds Sterility Lapses at NJ Drug Outsourcer
- URL: https://www.fdaweb.com/fda-finds-sterility-lapses-at-nj-drug-outsourcer/
- Published: 2025-11-24T12:00:00.000Z
- Updated: 2026-09-14T15:27:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160274

FDA investigators have cited Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-control deficiencies after a two-week inspection uncovered gaps in aseptic processing, environmental monitoring, and product quality review. Inspectors from the agency’s New Jersey District Office visited the facility between 7/28 and 8/11 and issued a [Form FDA 483](https://www.fda.gov/media/188960/download?ref=fdaweb.com) detailing three major observations. The findings raise concerns about the safety of the firm’s sterile drug products, including 70% ethanol solution packaged into 5 mL syringes.

During the inspection, FDA found that the company’s ISO 5 vertical laminar airflow hood — used for sterile filling — lacked a magnehelic gauge to measure pressure differentials between the ISO 5 hood and the surrounding ISO 7 room. Without pressure measurements, inspectors said there is “no assurance” that contaminants from the room do not enter the critical filling zone. Several batches of ethanol syringes produced in the unmonitored environment had already been distributed, the agency noted.

A second major observation focused on failures to establish and follow procedures designed to ensure sterility. According to FDA’s inspection form:

- Airflow “smoke studies” did not simulate routine operator interventions such as adding materials mid-fill or replacing tubing sets.
- Environmental monitoring during sterile filling was limited or absent. Inspectors noted that viable air samples were taken only at the start of operations, with no additional sampling during the remainder of the fill.
- Operators wore goggles with open vent holes that could shed particulates into the sterile environment.
- Equipment used to sterilize components was not properly qualified. The firm used biological indicators with inadequate organism counts and did not verify their population or identity upon receipt.

Additionally, investigators found that Molecular PharmaGroup lacked any written procedure for conducting annual product reviews and had not performed required reviews for numerous batches manufactured in 2024\. Such reviews are essential for identifying trends, deviations, and the need for specification changes, they said.