Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-15.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2026 – 15 May 2026 | Human Drugs | 483 | View 483 → |
| 30 Jun 2025 – 8 Jul 2025 | Human Drugs | Clean | |
| 28 Mar 2024 – 5 Apr 2024 | Human Drugs | 483 | View 483 → |
| 7 Feb 2023 – 16 Feb 2023 | Human Drugs | 483 | View 483 → |
| 28 Jan 2019 – 1 Feb 2019 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 May 2026
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Brandy N Lepage, Jessica S Estriplet
15 May 2026
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Brandy N Lepage, Jessica S Estriplet
15 May 2026
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Brandy N Lepage, Jessica S Estriplet
15 May 2026
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Brandy N Lepage, Jessica S Estriplet
15 May 2026
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Brandy N Lepage, Jessica S Estriplet
Investigators
FDA investigators tied to this site in the record.
Kellia N Hicks2 insp.
Brandy N Lepage1 insp.
Jessica S Estriplet1 insp.
Patty P Kaewussdangkul1 insp.
Xiaokuang Lai1 insp.
Bijoy Panicker1 insp.
Nicholas A Violand1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Emcure Pharmaceuticals Limited's 3 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat