India’s Hikal Limited has been hit with an FDA warning letter chiding the drug ingredients manufacturer for failing to uncover the cause of dozens of complaints of metal contamination in its products.
The regulatory rebuke follows the FDA's early February inspection of the company’s Jigani active pharmaceutical ingredient (API) facility in the Indian state of Karnataka. The FDA had previously issued a Form 483 as a result of its findings during the inspection.
In the letter, which was posted on the agency’s website earlier this week, the FDA estimated that Hikal had initially received 22 complaints since 2020 related to metal contamination in its API products.
After looking into the issue, Hikal determined that the metallic particles turning up in its products were likely left over following improper equipment cleaning, although the company admitted that it had not identified the root cause of the problem.
Hikal also claimed that the metallic contaminants were "beyond the detection limit" of the metal detector used to screen for particles in its API, according to the FDA.
The FDA concluded the company’s response was inadequate and noted that following Hikal's own investigation into the issue, its inspectors uncovered 28 more complaints of foreign material in the company's products.
“The current performance of the metal detector does not provide adequate assurance that previous API lots met established safety and quality standards,” the agency said in its write-up. "Also, your conclusion that your metal detector works adequately stands in contrast to customer complaints indicating contamination with metallic particles."
The company also failed to properly determine if its “equipment’s design and materials are suitable for API production without introducing contamination risks,” the FDA said, adding that Hikal didn’t adequately evaluate cleaning procedures and in-process controls “to prevent the presence of metal particles in your API.”
Hikal was also cited for failing to have a system in place for the re-evaluation of approved suppliers of critical materials.
The company, which inked a deal back in 2008 to supply Pfizer with APIs, was given 15 days from the date the warning was issued to respond or risk having its Jigani plant placed on the FDA's import alert list, which would prevent products manufactured at the facility from entering the U.S.