Nosch Labs Pvt. Ltd.
Form 483 issued September 13, 2024 · Hyderabad, India
- Inspection
- Sep 9 – Sep 13, 2024
- Investigators
- Lata Mathew· Logan T. Williams
- Observations
- 6
- Pages
- 4
- FEI number
- 3009250999
In short: On September 13, 2024, FDA issued a Form 483 with 6 observations to Nosch Labs Pvt. Ltd. in Hyderabad, Telangana (FEI 3009250999) after an inspection that ran Sep 9 – Sep 13, 2024. The investigators were Lata Mathew and Logan T. Williams. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
4 of 6 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls were not enabled on testing equipment used and suitability of method used for release…
- 02
Qualified Reference standards are not…
- 03
Analytical Test Methods are…
- 04
Process validation was not reproducible for…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmNosch Labs Pvt. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nosch Labs Pvt. Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Nosch Labs Pvt. Ltd.?
Lata Mathew and Logan T. Williams are named on this Form 483, for the inspection of Sep 9 – Sep 13, 2024. Each investigator has a profile showing what they cite most.
When was Nosch Labs Pvt. Ltd. inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2024, and the Form 483 is dated September 13, 2024.
How do I get the full Form 483 for Nosch Labs 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.