FDA puts New Jersey drug ingredients maker Spectrum through the wringer in scathing Form 483

With observations ranging from dirty packing rooms to incomplete lab control records, Spectrum Laboratory Products’ new FDA manufacturing write-up reads like a guide on what not to do when producing drug ingredients.

The active pharmaceutical ingredient (API) maker was chastised by the U.S. drug regulator in a 14-observation Form 483 following inspections of three of Spectrum facilities in New Brunswick, New Jersey, earlier this year.

In total, FDA officials carried out seven inspections across the trio of sites, which included the U.S. headquarters of Spectrum’s chemical manufacturing division, according to the company’s website.

Aside from manufacturing and documentation slip-ups, the FDA chastised Spectrum’s lackluster response to customer complaints, plus its failure to investigate “critical deviations” in its production and storage procedures.

Spectrum’s shortfalls begin to make sense within the context of the FDA’s final observation that the company lacks enough qualified personnel to perform and supervise API manufacturing.

Specifically, Spectrum’s staffers are “carrying out duties without being provided any training,” according to the FDA.

The FDA said the API maker has received 5,679 total complaints between November 2021 and February 2023, while its quality unit has only reviewed 58 of them. In turn, the FDA said it's unconvinced that all API complaints are being reviewed and fully investigated by Spectrum’s quality team.

The remaining observations in the FDA Form 483 are more typical of this sort of manufacturing write-up. They describe issues such as poor controls against cross-contamination and poor warehouse controls.

The regulatory wrist-slap marks Spectrum’s second run-in with the FDA this year. Back in January, the company kicked off a voluntary recall of three lots of bulk compound epinephrine following customer complaints about discoloration. The product pull covered bulk API distributed across the U.S. and Canada.