FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
“U.S. inspectors have uncovered new and dangerous breakdowns in drugmaking at an Indian factory owned by Sun Pharma that produces generic medications for American consumers.
The latest problems come 2 1/2 years after the Food and Drug Administration gave the facility a special pass to continue sending certain drugs made there to the United States, even after the factory was officially banned from the U.S. market.“
Sun Pharma is the biggest pharmaceutical manufacturer in India and one of the biggest in the world. No company is exempt from having these problems in India or elsewhere, but it underlines yet again that if you are playing russian roulette with meds from the biggest and most established companies out there, you are taking all the more risks with smaller companies that have no presence in the US and not even nominal FDA checks.
Claude Opus 4:
Based on my research, here’s a comprehensive overview of India’s most important pharmaceutical manufacturers and their quality standards:
Top Indian Pharmaceutical Companies (2025)
1. Sun Pharmaceutical Industries
Market Cap: ₹3,71,000 crore ($28.7 billion)
Global Ranking: 4th largest specialty generic manufacturer globally
Quality Standards:
43 manufacturing facilities with 14 dedicated to APIs
Faced FDA warning letter for CGMP violations including inadequate cleaning and maintenance of equipment, with repeated violations at multiple sites
Despite challenges, maintains strong global presence in 100+ countries
Quality: Strong emphasis on regulated markets (US, Japan, Australia)
Quality Standards Overview
FDA Compliance Performance
In 2023, Indian facilities showed better regulatory outcomes than global average, with 13% classified as OAI (Official Action Indicated) versus 15% global average
In 2024, OAI cases decreased to 14 (from 18 in 2023), showing improvement in compliance
Indian companies secure 48-50% of all USFDA abbreviated new drug approvals
WHO Standards
India supplies 70% of WHO vaccines and contributes 57% of APIs to WHO’s prequalified list
India has the highest number of USFDA-compliant pharmaceutical manufacturing facilities
Common Quality Issues
Data Integrity: Multiple companies faced violations for inadequate record-keeping
Manufacturing Practices: Issues with cleaning procedures, quality control
Investigation Procedures: Inadequate investigation of quality complaints
Below is an at‑a‑glance map of India’s biggest drug makers (by market cap / revenue in FY 2024‑25¹) and how regulators have judged their manufacturing quality since 2023. Legend — Overall quality signal:
▲ Robust = no open FDA/EMA/WHO findings & no quality‑linked recalls in the last two years.
△ Mixed = isolated recalls or Form 483 observations that were either minor or quickly remediated.
▼ Red flag = recent FDA Warning Letter, EMA GMP‑non‑compliance statement, import alert or multiple class‑II recalls.
Rank ≈
Company (HQ)
What makes it “important”
Recent quality record (2023‑25)
Signal
1
Sun Pharmaceutical Inds. (Mumbai)
India’s largest pharma group; ₹52,578 cr FY 25 revenue
Recalls of oral contraceptives (2023) and multiple Form 483s across Indian plants; one Nagpur site cleared with zero observations in 2024 Fierce PharmaFierce PharmaFierce Pharma
△
9
Aurobindo Pharma / Eugia (Hyderabad)
Top 5 U.S. generic filer
Five separate Form 483s since 2024; Eugia sterile plant now “Official Action Indicated” for microbial‑control failures Fierce PharmaFierce Pharma
No recent GMP citations; June 2025 FDA pre‑notice relates only to trial‑data posting, not manufacturing U.S. Food and Drug Administration
▲
11
Intas Pharmaceuticals (Ahmedabad)
Large private generics group (Accord EU)
2023 FDA warning letter after inspectors found “truckloads of shredded QC records” and data integrity breaches; EU placed site under GMP non‑compliance Fierce PharmaRAPS
Market Importance: Ranked roughly by FY 24‑25 revenue/market‑cap (Sun > Divi’s > Cipla > Dr Reddy’s … Granules).¹
Quality Signals: Drawn from public FDA/EMA documents, WHO alerts, CDSCO test failures and major recalls in 2023‑25.
Granularity: A single company can operate 10‑40 plants. One red‑flag site does not condemn every product, but persistent multi‑site findings generally correlate with higher recall rates and import alerts.
Caveats: “Good” (▲) does not guarantee perfect quality; it only means no regulatory body has publicized a serious lapse recently. Always check the specific ANDA holder and lot when you buy a generic drug.
Bottom line
Indian pharma ranges from world‑class API and biosimilar outfits (Divi’s, Biocon) to serial violators still struggling with data integrity (Intas) or contamination controls (Sun’s Halol, Aurobindo’s Eugia). When product choice matters—e.g., long‑term chronic therapy—checking who made your pill and how often that firm has been on the FDA’s radar is your best defence against hidden impurities.
¹ Forbes India market‑cap list (June 19 2025) & FY 25 pharma‑results press releases were used to establish relative size.
“Meanwhile, a Daewoo Pharm site in Busan, Korea, received a warning letter on July 2 after an FDA inspection earlier this year. The company had replied to a previous Form 483 in February, but its responses were largely viewed as inadequate, leaving the plant’s products currently considered “adulterated” by the FDA due to “significant” violations of manufacturing regulations.
The agency listed five main concerns in the contamination, quality control and cleanliness realms with evidence ranging from improper sterilization of equipment to inadequate environmental monitoring and visual inspection. Some of the more damning examples cited by the FDA was mold in “multiple areas” of the facility that Daewoo failed to properly investigate, plus late testing on certain samples despite a “substantial number of complaints for burning or redness,” which suggested potential contamination.
Daewoo’s site has also failed to maintain a robust sampling and testing plan for a component. Contamination of that component at other manufacturers has in the past resulted in “various lethal poisoning incidents in humans worldwide,” the FDA notes.
The Korean drugmaker specializes in ophthalmology and pledges to “take care of the eye health of people across the world.” The company’s Busan plant makes tablets, capsules and eye drops and sells its products in Targets and Walgreens across the U.S.”
I think this type of information could be very deceiving… I don’t believe that the FDA isn’t going to care much about Domestic India Pharma, so the fact that they’ve gotten no FDA warning letters means nothing… I think this is an example of how LLMs are still in their infancy and not to be entirely trusted or believed.