Panacea Biotec Pharma Limited Malpur, Baddi
Form 483 issued October 12, 2023 · Solan, India
- Inspection
- Oct 3 – Oct 12, 2023
- Investigators
- Muna Algharibeh· Sandra A. Boyd
- Observations
- 1
- Pages
- 8
- FEI number
- 3007187282
In short: On October 12, 2023, FDA issued a Form 483 with 1 observation to Panacea Biotec Pharma Limited Malpur, Baddi in Solan, India (FEI 3007187282) after an inspection that ran Oct 3 – Oct 12, 2023. The investigators were Muna Algharibeh and Sandra A. Boyd. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113(b) (1×)
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 not…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmPanacea Biotec Pharma Limited Malpur, Baddi history
All 5 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 Panacea Biotec Pharma Limited Malpur, Baddi?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Panacea Biotec Pharma Limited Malpur, Baddi?
Muna Algharibeh and Sandra A. Boyd are named on this Form 483, for the inspection of Oct 3 – Oct 12, 2023. Each investigator has a profile showing what they cite most.
When was Panacea Biotec Pharma Limited Malpur, Baddi inspected by FDA?
The inspection ran Oct 3 – Oct 12, 2023, and the Form 483 is dated October 12, 2023.
How do I get the full Form 483 for Panacea Biotec Pharma Limited Malpur, Baddi?
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.