Panacea Biotec Pharma Limited Malpur, Baddi
Form 483 issued June 8, 2022 · Baddi, India
- Inspection
- May 30 – Jun 8, 2022
- Investigators
- Revers Cynthia Jim· Wayne D. McGrath
- Observations
- 8
- Pages
- 10
- FEI number
- 3007187282
In short: On June 8, 2022, FDA issued a Form 483 with 8 observations to Panacea Biotec Pharma Limited Malpur, Baddi in Baddi, Himachal Pradesh (FEI 3007187282) after an inspection that ran May 30 – Jun 8, 2022. The investigators were Revers Cynthia Jim and Wayne D. McGrath. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 5 of 8 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Your examination and testing of samples did not assure that the drug product and in-process…
This inspection in context
Revers Cynthia Jim
1 document · 2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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
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 8 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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?
Revers Cynthia Jim and Wayne D. McGrath are named on this Form 483, for the inspection of May 30 – Jun 8, 2022. Each investigator has a profile showing what they cite most.
When was Panacea Biotec Pharma Limited Malpur, Baddi inspected by FDA?
The inspection ran May 30 – Jun 8, 2022, and the Form 483 is dated June 8, 2022.
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.