FDA Finds Concerns During Dr. Reddy’s, Kilitch Plant Inspections in India

Two companies with multiple recalls in recent US Food and Drug Administration (FDA) Enforcement Reports received a combined 2 dozen FDA “observations” after October 2023 inspections of their India-based production plants.

According to the Form 483 report, observations “do not represent a final agency determination regarding … compliance.” Companies with objections to observations or who have implemented corrective plans can submit them to the FDA for review.

Dr. Reddy’s Laboratories Ltd. received a 23-page Form 483 with a total 10 observations after an inspection of its Telangana, India, plant October 19 through October 27, 2023.

“[T]he FDA chided Dr. Reddy’s for missteps around building and equipment maintenance, deficient quality control activities, mishandling of complaints, and more,” Fierce Pharma reported. Specifically, equipment was not cleaned thoroughly enough to prevent contamination, equipment failed to meet calibration requirements, buildings were not “in a good state of repair,” and processing areas were not properly maintained to prevent mix-up or contamination.

Fierce Pharma also reported “lackluster quality control, deficient written specifications, failure to follow up on batch failures and discrepancies, as well as inadequate responses to written and oral complaints from customers” as concerns cited in Dr. Reddy’s Form 483. Among recent Dr. Reddy’s recalls were 1-mg tacrolimus capsules in the January 17, 2024, FDA Enforcement Report (a 0.5-mg tacrolimus capsule was discovered in a bottle) and misprinted glimepiride tablets in the February 14, 2024, FDA Enforcement Report.

Kilitch Healthcare India Limited also received a Form 483 after the FDA visited its Maharashtra, India, plant October 12 through October 20, 2023. The visit yielded a total 14 observations.

Fierce Pharma cited FDA observations of unclean and unsanitary production buildings that included “cracks in walls, dust build-up on air vents, leaks, stagnant water, water stains, and peeling paint, among other maintenance shortfalls.” Additionally, the company did not complete batch control records, and its written stability program for drugs failed to include meaningful test methods, according to the article.

The February 14, 2024, FDA Enforcement Report contained Class I recalls, which warn use of the products could cause serious adverse health consequences of death, for some 27 over-the-counter eye drop products manufactured by Kilitch Healthcare India Limited. The eye drops were sold throughout the United States by retailers including CVS Pharmacy, Rite Aid, Target, and Walmart.

A November 15, 2023, statement announcing the recall, issued by Kilitch Healthcare India Limited, Mumbai, Maharashtra, described “potential safety concerns after FDA investigators found insanitary conditions.”

Reference

Kansteiner F. Dr. Reddy's scolded for maintenance shortfalls in new FDA Form 483 filing. Fierce Pharma. November 30, 2023. Accessed February 16, 2024. https://www.fiercepharma.com/pharma/dr-reddys-scolded-maintenance-shortfalls-india-new-fda-form-483