Site records / Himachal Pradesh / FEI 3007187282

Panacea Biotec Pharma LimitedSolan, Himachal Pradesh

FDA-registered drug establishment in Solan, Himachal Pradesh: analysis, manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
8
Last inspection
Oct 2023 · OAI
Warning letters to this FEI
1
Import alerts at this address
0
US border refusals, 2 years
0
The site dossier

This site, graded.
Every fact sourced.

  • A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
  • Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
  • Warning-letter violations, numbered and labelled
  • Import-alert history rebuilt from the archive, each listing checked against this address
  • Border refusals by product, and the company's other sites, each graded
  • A hash of every source read, so the PDF can be checked against the record

On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.

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Inspections

8 FDA inspections of this FEI, by end date; 8 with a posted classification.

  1. 12 Oct 2023OAI · Official Action IndicatedDrug Quality Assurance · 9 citations posted
  2. 8 Jun 2022OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
  3. 30 Apr 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 13 Dec 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 11 Dec 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  6. 25 Oct 2013VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  7. 7 Sep 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  8. 13 Nov 2009NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 24 Sep 2020Warning Letter · CDER

Import alerts in force

No listing in force under this firm's name.

Form 483s released by FDA

  1. 12 Oct 2023Form 483 · 8 pages Source

Registration

FEI
3007187282
DUNS
857979552
Registered as
PANACEA BIOTEC PHARMA LIMITED
Registrant
PANACEA BIOTEC PHARMA LIMITED
Address
Pharma Block, Malpur, Baddi, Solan, Himachal Pradesh 173205, India (IND)
Operations
ANALYSIS, MANUFACTURE
Registration expires
31 Dec 2026

Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.

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