BioMylz Pvt. Ltd.

FDA inspection history in Bangalore, India, 2020 to 2026

2
Form 483s
1
Warning letter

Every document, by year

  • Warning letter
  • Form 483

2020: one Form 483; 2026: one warning letter and one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2020One Form 483, at Bangalore, India.
  2. 2026One warning letter and one Form 483, at Bangalore, India.
  3. 2026The longest 483 on file: 7 observations over 6 pages.

Cited most

Across all BioMylz Pvt. observations on file

  • 21 CFR 211.84
    Testing and approval or rejection of components, drug product containers, and closures
    1

The complete BioMylz Pvt. file.

All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$297

The price of the documents, added to your cart together

Sites

Also: one document not tied to a site.

Documents

3 on file, newest first
DateDocumentPrice
2026-07-13Warning letter Warning letter$99
2026-02-09483 Form 483$99
2020-02-07483 Form 483$99

Investigators on these documents

Jose E. Melendez (1)Saied A. Asbagh (1)

FEI number 3013697420 · most recent document Jul 13, 2026

About BioMylz Pvt. Ltd.

How many FDA Form 483s has BioMylz Pvt. Ltd. received?

FDA Intel has 2 Form 483s on file for BioMylz Pvt. Ltd.; the most recent is dated Feb 9, 2026.

When was BioMylz Pvt. Ltd. last inspected by FDA?

The most recent FDA inspection document on file for BioMylz Pvt. Ltd. is a Form 483 dated Feb 9, 2026.

What did FDA cite at BioMylz Pvt. Ltd.?

The regulations cited most in the observations on file for BioMylz Pvt. Ltd. are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 1 time.

Has BioMylz Pvt. Ltd. received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for BioMylz Pvt. Ltd.; the most recent is dated Jul 13, 2026.