Nectar Life Sciences Limited
Form 483 issued March 10, 2023 · Solan, India
- Inspection
- Mar 2 – Mar 10, 2023
- Investigators
- Anastasia M. Shields· Jeffrey P. Raimondi
- Observations
- 7
- Pages
- 12
- FEI number
- 3008932049
In short: On March 10, 2023, FDA issued a Form 483 with 7 observations to Nectar Life Sciences Limited in Solan, Himachal Pradesh (FEI 3008932049) after an inspection that ran Mar 2 – Mar 10, 2023. The investigators were Anastasia M. Shields and Jeffrey P. Raimondi. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Written records of investigations into unexplained discrepancies do not always include…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmNectar Life Sciences Limited history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nectar Life Sciences Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Nectar Life Sciences Limited?
Anastasia M. Shields and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Mar 2 – Mar 10, 2023. Each investigator has a profile showing what they cite most.
When was Nectar Life Sciences Limited inspected by FDA?
The inspection ran Mar 2 – Mar 10, 2023, and the Form 483 is dated March 10, 2023.
How do I get the full Form 483 for Nectar Life Sciences 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.