BioMylz Pvt. Ltd.
Form 483 issued February 7, 2020 · Bangalore, India
- Inspection
- Feb 3 – Feb 7, 2020
- Investigator
- Saied A. Asbagh
- Observations
- 1
- Pages
- 12
In short: On February 7, 2020, FDA issued a Form 483 with 1 observation to BioMylz Pvt. Ltd. in Bangalore, India after an inspection that ran Feb 3 – Feb 7, 2020. The investigator was Saied A. Asbagh. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmBioMylz Pvt. Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioMylz Pvt. Ltd.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected BioMylz Pvt. Ltd.?
Saied A. Asbagh is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2020. Each investigator has a profile showing what they cite most.
When was BioMylz Pvt. Ltd. inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2020, and the Form 483 is dated February 7, 2020.
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.