Panacea Biotec Pharma Limited Malpur, Baddi
FDA inspection history across 3 sites, 2019 to 2023
- 4
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2019: one Form 483; 2020: one close-out letter and one Form 483; 2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–23Four Form 483s and one close-out letter, at Baddi, India; New Delhi, India and Solan, India.
- 2022The longest 483 on file: 8 observations over 10 pages at Baddi, India.
Cited most
Across all Panacea Biotec Pharma Limited Malpur, Baddi observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.167(a)Special testing requirements1
The complete Panacea Biotec Pharma Limited Malpur, Baddi file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Baddi, India
Three Form 483s · 2019 to 2022 · 17 observations
Latest: Form 483, Jun 8, 2022 →Solan, India
One Form 483 · 2023 · 1 observation
Latest: Form 483, Oct 12, 2023 →New Delhi, India
One close-out letter · 2020
Latest: Close-out, Sep 24, 2020 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-12 | 483 Form 483 | Solan, India | 1 | $99 |
| 2022-06-08 | 483 Form 483 | Baddi, India | 8 | $99 |
| 2020-09-24 | Close-out Close-out letter | New Delhi, India | — | $99 |
| 2020-02-20 | 483 Form 483 | Baddi, India | 7 | $99 |
| 2019-08-09 | 483 Form 483 | Baddi, India | 2 | $99 |
Investigators on these documents
Jeffrey P. Raimondi (2)Muna Algharibeh (1)Philip F. Istafanos (1)Revers Cynthia Jim (1)Sandra A. Boyd (1)Wayne D. McGrath (1)
FEI number 3007187282 · most recent document Oct 12, 2023
About Panacea Biotec Pharma Limited Malpur, Baddi
How many FDA Form 483s has Panacea Biotec Pharma Limited Malpur, Baddi received?
FDA Intel has 4 Form 483s on file for Panacea Biotec Pharma Limited Malpur, Baddi; the most recent is dated Oct 12, 2023.
When was Panacea Biotec Pharma Limited Malpur, Baddi last inspected by FDA?
The most recent FDA inspection document on file for Panacea Biotec Pharma Limited Malpur, Baddi is a Form 483 dated Oct 12, 2023, for the site in Solan, India.
What did FDA cite at Panacea Biotec Pharma Limited Malpur, Baddi?
The regulations cited most in the observations on file for Panacea Biotec Pharma Limited Malpur, Baddi are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times.