FDA-Inspected Site

BioMylz Pvt. Ltd.

2 FDA inspections are on record for BioMylz Pvt. Ltd. in Bengaluru, India.

483· Form 483 issued

Bengaluru, India · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-09.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Feb 2026 – 9 Feb 2026Human DrugsWLOn file
3 Feb 2020 – 7 Feb 2020Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

7 Feb 2020
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Saied A Asbagh

7 Feb 2020
21 CFR 211.111

Establishment of time limitations

Cited by Saied A Asbagh

7 Feb 2020
21 CFR 211.115(a)

Reprocessing procedures not written or followed

Cited by Saied A Asbagh

7 Feb 2020
21 CFR 211.122(d)

Label storage access limited to authorized personnel

Cited by Saied A Asbagh

7 Feb 2020
21 CFR 211.165(a)

Testing and release for distribution

Cited by Saied A Asbagh

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.115(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.52Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind BioMylz Pvt. Ltd.'s 2 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