BioMylz Pvt. Ltd.
Form 483 issued February 9, 2026
- Inspection
- Feb 4 – Feb 9, 2026
- Investigator
- Jose E. Melendez
- Observations
- 7
- Pages
- 6
- FEI number
- 3013697420
In short: On February 9, 2026, FDA issued a Form 483 with 7 observations to BioMylz Pvt. Ltd. (FEI 3013697420) after an inspection that ran Feb 4 – Feb 9, 2026. The investigator was Jose E. Melendez.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 02
There are no written procedures for production and process controls designed to assure that the OTC…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmBioMylz Pvt. Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at BioMylz Pvt. Ltd.?
FDA listed 7 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected BioMylz Pvt. Ltd.?
Jose E. Melendez is named on this Form 483, for the inspection of Feb 4 – Feb 9, 2026. Each investigator has a profile showing what they cite most.
When was BioMylz Pvt. Ltd. inspected by FDA?
The inspection ran Feb 4 – Feb 9, 2026, and the Form 483 is dated February 9, 2026.
How do I get the full Form 483 for BioMylz Pvt. Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.