Teyro Labs Private Limited
Form 483 issued March 3, 2023 · Oragadam, India
- Inspection
- Feb 20 – Mar 3, 2023
- Investigator
- Taichun Qin
- Observations
- 4
- Pages
- 5
- FEI number
- 3021389808
In short: On March 3, 2023, FDA issued a Form 483 with 4 observations to Teyro Labs Private Limited in Oragadam, Tamil Nadu (FEI 3021389808) after an inspection that ran Feb 20 – Mar 3, 2023. The investigator was Taichun Qin. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmTeyro Labs Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teyro Labs Private Limited?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Teyro Labs Private Limited?
Taichun Qin is named on this Form 483, for the inspection of Feb 20 – Mar 3, 2023. Each investigator has a profile showing what they cite most.
When was Teyro Labs Private Limited inspected by FDA?
The inspection ran Feb 20 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
How do I get the full Form 483 for Teyro Labs Private Limited?
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.