Panacea Biotec Pharma Limited Malpur, Baddi
Form 483 issued February 20, 2020 · Baddi, India
- Inspection
- Feb 10 – Feb 20, 2020
- Investigators
- Jeffrey P. Raimondi· Philip F. Istafanos
- Observations
- 7
- Pages
- 8
- FEI number
- 3007187282
In short: On February 20, 2020, FDA issued a Form 483 with 7 observations to Panacea Biotec Pharma Limited Malpur, Baddi in Baddi, Himachal Pradesh (FEI 3007187282) after an inspection that ran Feb 10 – Feb 20, 2020. The investigators were Jeffrey P. Raimondi and Philip F. Istafanos. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
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 211.42(c)(10)(iv)
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 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Panacea Biotec Pharma Limited Malpur, Baddi?
Jeffrey P. Raimondi and Philip F. Istafanos are named on this Form 483, for the inspection of Feb 10 – Feb 20, 2020. Each investigator has a profile showing what they cite most.
When was Panacea Biotec Pharma Limited Malpur, Baddi inspected by FDA?
The inspection ran Feb 10 – Feb 20, 2020, and the Form 483 is dated February 20, 2020.
How do I get the full Form 483 for Panacea Biotec Pharma Limited Malpur, Baddi?
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