Methodology

How data is collected

• Inspections and Form 483 observations — FDA Data Dashboard API (inspection classifications and citations), for sites in India. Updated daily.
• Warning letters — the FDA warning letter list (official export), daily.
• Import alerts — FDA Import Alert 66-40, India section, daily.
• Approvals — Drugs@FDA via openFDA: original ANDA/NDA approvals and tentative approvals, daily.
• Company filings — BSE corporate announcements, checked every 5 minutes for USFDA-related filings.

Confirmed vs reported

Records published by the FDA itself are shown as they are. Company filings are marked "reported by company" and are checked by a person before they appear on the site. FDA publishes inspection classifications with a delay, so a company filing may appear before the FDA record.

Matching plants to companies

FDA lists plants by legal name and FEI number. PharmaRoz matches them to listed companies using known company and subsidiary names. Matching is automatic and can miss renamed or acquired units; corrections are welcome.

Compliance score

A simple, size-fair summary of a company's USFDA record over the last 5 years, from 0 to 100:

• Inspection record: 100 × (NAI inspections + 0.6 × VAI inspections) ÷ all classified inspections. OAI inspections count as 0. Because it uses the share of inspections, a company with many plants is not penalised for being inspected more often.
• Minus 10 for each warning letter without a close-out letter (at most −30).
• Minus 10 for each of its sites currently on Import Alert 66-40 (at most −30).
• A company with no classified inspections starts at 100 before these deductions.

The result is rounded and kept between 0 and 100. It describes past regulatory records only. It is not a rating of the company or its stock and says nothing about future results.

Corrections

Errors reported to contact@pharmaroz.com are checked against the original source and fixed. Significant corrections will be listed here with the date.