Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-01-27.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Jan 2025 – 27 Jan 2025 | Human Drugs | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
Mixtures: uniformity and concentration
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Conduct: identification of test specimens
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Final report: names of those involved
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Management: personnel understand their functions
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Study director: all data recorded and verified
Cited by Hugh M Mcclure, Zhou Chen, Mark J Seaton, Annabelle Crusan, Alanna L Mussawwir Bias, Kerun Hardeo, Simona M Bancos
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 58.113(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.130(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.185(a)(10) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.31(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.33(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.35(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.81(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 58.90(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Palamur Biosciences Private Limited's 1 Form 483
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