NEULAND LABORATORIES LIMITED
Form 483 issued June 21, 2019 · Domadugu Village, India
- Inspection
- Jun 17 – Jun 21, 2019
- Investigator
- Jennifer L. Huntington
- Observations
- 5
- Pages
- 4
- FEI number
- 3003289270
In short: On June 21, 2019, FDA issued a Form 483 with 5 observations to NEULAND LABORATORIES LIMITED in Domadugu Village, Telangana (FEI 3003289270) after an inspection that ran Jun 17 – Jun 21, 2019. The investigator was Jennifer L. Huntington. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Failure to validate and monitor the water purification system to ensure that water…
- 03
Failure to investigate, report, and prevent communication failures in analytical data transfer. Your firm failed to…
- 04
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would…
This inspection in context
Jennifer L. Huntington
31 documents · 2015–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmNEULAND LABORATORIES LIMITED 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 NEULAND LABORATORIES LIMITED?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected NEULAND LABORATORIES LIMITED?
Jennifer L. Huntington is named on this Form 483, for the inspection of Jun 17 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was NEULAND LABORATORIES LIMITED inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
How do I get the full Form 483 for NEULAND LABORATORIES 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.