Panacea Biotec Pharma Limited Malpur, Baddi
Form 483 issued August 9, 2019 · Baddi, India
- Inspection
- Aug 5 – Aug 9, 2019
- Investigator
- Jeffrey P. Raimondi
- Observations
- 2
- Pages
- 3
- FEI number
- 3007187282
In short: On August 9, 2019, FDA issued a Form 483 with 2 observations to Panacea Biotec Pharma Limited Malpur, Baddi in Baddi, Himachal Pradesh (FEI 3007187282) after an inspection that ran Aug 5 – Aug 9, 2019. The investigator was Jeffrey P. Raimondi. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.100 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Changes to written procedures are not drafted, reviewed and approved by…
- 02
Written records of investigation of a drug complaint do…
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 211.100
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 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Panacea Biotec Pharma Limited Malpur, Baddi?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Aug 5 – Aug 9, 2019. Each investigator has a profile showing what they cite most.
When was Panacea Biotec Pharma Limited Malpur, Baddi inspected by FDA?
The inspection ran Aug 5 – Aug 9, 2019, and the Form 483 is dated August 9, 2019.
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.