Where are the bugs? FDA knocks Indian manufacturer for 'crude' microbe testing

Bacteria
Panacea's employees, in one case, identified just one of a possible 6,360 microbes in an isolated sample, the FDA contended. (Spero)

India's Panacea Biotec has had a long history of run-ins with global regulators in the past, including being stripped of its prequalified vaccine status nearly a decade ago. Now, FDA investigators have accused the company of failing to properly identify microbes at one of its plants—questioning the quality of its aseptic manufacturing.

FDA investigators blasted Panacea Biotec's Himachal Pradesh, India, aseptic manufacturing facility for failing to properly identify and record isolated microbes, including using an "incomplete and crude" visual identification process, according to a warning letter posted online Tuesday.

In one case in 2019, Panacea workers identified just one microbe of a possible 6,360 isolated from one of the facility's aseptic rooms, the FDA said. The ability to properly identify microbes—preferably down to the genus level, the FDA said—is important, because it can help companies identify possible lines of contamination in their facilities.

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"Because your firm lacks microbial identification data from environmental monitoring, you lack basic information needed to evaluate the ongoing state of control of your aseptic manufacturing operations," the letter stated. 

SPECIAL REPORT: The most significant FDA warning letters of 2019

Panacea responded to the FDA's Form 483 letter following its inspection, saying it would enhance its identification program to better identify isolated microbes. That response didn't cut it, the FDA said: The company didn't pledge to identify microbes down to the genus level. 

The FDA also knocked Panacea for improper waterborne endotoxin testing, including—in one notable example—an incident in which one of the workers timed the test off a wall clock that "had not been properly calibrated," investigators said.

Panacea said it would change its endotoxin testing regimen, but the FDA said its response didn't go far enough to adequately review its past testing. 

Panacea also had issues with establishing an environmental monitoring system for its vaccines and sterile injectables, including unclear triggers to investigate non-viable particles in its drug batches. 

RELATED: Panacea Biotec accused of selling expired vaccines

Panacea has had a long, troubled history with global regulators, most notably being dropped from the World Health Organization's prequalified pentavalent vaccine supplier list back in 2011.

In April 2013, inspectors froze the sale of more than 15,000 vials of one of Panacea's pentavalent vaccines after discovering that someone had tampered with expiry dates. Panacea claimed it was given permission to make the change, and new labels were pasted on top of old ones so the work could be done while keeping the vaccines refrigerated.

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