FDA 483's
FDA Form 483 Inspection Observation Database
Company-wise FDA Form 483 observation records, regulatory resources, GMP learning, searchable source records and pharmaceutical microbiology inspection intelligence.
FDA Form 483 observations are inspectional observations made by FDA investigators during an inspection. They are not, by themselves, final FDA determinations of compliance or non-compliance.
The analytical risk categories used in a future expanded version of this database will be classifications created by PharmaceuticalMicrobiology.in for educational analysis. They are not official FDA Critical, Major or Minor classifications.
This page currently focuses on the reviewed source records and company-wise observation counts. Individual observations should be separately reviewed and classified before analytical conclusions are assigned.
FDA 483 Dashboard
Company-wise FDA 483 Observations
Observation Count by Company / Facility
Descriptive count of verified observations from the reviewed source records. Dabur is excluded from the chart until its source count is verified. This is not a compliance ranking.
FDA 483 Observation Database
| ID | Company / Facility | Observation Record | Status | Year | Source |
|---|
FDA 483 Company Database
CIPLA Limited
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
EUGIA Pharma Specialities Limited
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Alkem Laboratories Limited
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Zydus Lifesciences Limited
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
VA San Diego Healthcare Systems
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Richmond VA Medical Center
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Cascade Specialty Pharmacy, LLC
FDA inspection observations and practical GMP analysis.
View FDA 483 Article →
Strides Pharma Science Limited
FDA inspection observations and practical GMP lessons.
View FDA 483 Article →
Emcure Pharmaceuticals Limited
FDA inspection observations and practical GMP lessons.
View FDA 483 Article →
Phoenix – Arizona
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Dr. Reddy's Laboratories Ltd.
FDA inspection observations and regulatory analysis.
View FDA 483 Article →
Dabur India Limited
New 2026 FDA Form 483 source record added to the database. The linked article is retained for direct review.
The “7” appearing in the source URL is not being treated as a verified observation count until the article can be directly reviewed.
View Dabur FDA 483 Article →Hetero Labs Limited, Unit-IX
API manufacturing facility. Inspection: 19–26 September 2025. FEI 3009093782. Investigators: Tamil Arasu, Lisa L. Flores and Pratik S. Upadhyay.
Quality Unit/laboratory governance • API warehouse • batch/yield reconciliation • data integrity • label reconciliation • OOS investigation.
View Hetero FDA 483 Article →Dabur India & Hetero Labs — Added to Database
Dabur India Limited — 2026
Source: Dabur India FDA Form 483 2026
Database status: Source link added; observation count pending direct source verification.
The article URL contains “2026-7”, but the dashboard does not automatically interpret a URL slug as proof of seven observations. Once the source article is directly reviewable, the observation count and individual observation themes can be populated here.
Open Dabur Source Article →Hetero Labs Limited, Unit-IX — 2025
Inspection: 19–26 September 2025
FEI: 3009093782
Establishment: API Manufacturer
Investigators: Tamil Arasu; Lisa L. Flores; Pratik S. Upadhyay
Verified observations: 6
- Quality Unit / unregistered testing laboratory
- Undocumented API warehouse
- Batch records / yield discrepancies
- Document control / data integrity
- Identification-label reconciliation
- OOS documentation and investigation
The source article separately distinguishes FDA observations from PharmaceuticalMicrobiology.in's educational root-cause, CAPA and GMP-learning analysis.
Open Hetero Source Article →How This FDA 483 Database Works
Each FDA Form 483 is treated as an inspection source record. Individual observations can subsequently be entered as separate database records after review of the corresponding source article.
Future observation-level fields may include company, facility, inspection date, observation number, GMP category, sub-category, product type, microbiology relevance, data-integrity relevance, contamination-control relevance and analytical risk category.
This structure is designed to support future company-wise, category-wise, microbiology-focused, risk-focused and year-wise regulatory intelligence analysis.
Current database status: 13 company/source records are included. Hetero Labs Limited Unit-IX has six source-verified observation themes. Dabur India Limited is included as a source record, but its observation count remains pending direct verification. Detailed risk/category classification should be completed from the underlying source articles before analytical conclusions are displayed.
FDA Regulatory Resources
Explore additional FDA regulatory resources covering warning letters, guidance documents, inspection expectations and pharmaceutical GMP compliance topics.
Comments
Post a Comment
💬 Share your thoughts or questions about this topic below.
Ask your real microbiology lab problems, deviations, or GMP doubts here.
I personally reply with practical solutions from industry experience.