Immacule Lifesciences Private Limited
Form 483 issued June 20, 2022 · Nalagarh, India
- Inspection
- Jun 9 – Jun 20, 2022
- Investigators
- Cynthia Jim· Wayne D. McGrath
- Observations
- 8
- Pages
- 11
- FEI number
- 3014210753
In short: On June 20, 2022, FDA issued a Form 483 with 8 observations to Immacule Lifesciences Private Limited in Nalagarh, Himachal Pradesh (FEI 3014210753) after an inspection that ran Jun 9 – Jun 20, 2022. The investigators were Cynthia Jim and Wayne D. McGrath. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment for adequate control over air pressure, humidity, and temperature is not provided when appropriate for…
- 02
The written stability testing…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmImmacule Lifesciences Private 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 211.46
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Immacule Lifesciences Private Limited?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Immacule Lifesciences Private Limited?
Cynthia Jim and Wayne D. McGrath are named on this Form 483, for the inspection of Jun 9 – Jun 20, 2022. Each investigator has a profile showing what they cite most.
When was Immacule Lifesciences Private Limited inspected by FDA?
The inspection ran Jun 9 – Jun 20, 2022, and the Form 483 is dated June 20, 2022.
How do I get the full Form 483 for Immacule Lifesciences 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.