Site records / Andhra Pradesh / FEI 3008316085
Pfizer Healthcare India Private LimitedAnakapalli, Andhra Pradesh
FDA-registered drug establishment in Anakapalli, Andhra Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 7
- Last inspection
- Oct 2022 · VAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 0
- US border refusals, 2 years
- 1
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
7 FDA inspections of this FEI, by end date; 7 with a posted classification.
- 18 Oct 2022VAI · Voluntary Action IndicatedDrug Quality Assurance · 1 citation posted
- 6 Sep 2019OAI · Official Action IndicatedDrug Quality Assurance · no citations posted
- 21 Sep 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
- 17 Mar 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 8 Sep 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 25 Feb 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 22 Mar 2014VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 25 Mar 2020Warning Letter · CDER
- 28 May 2013Warning letter to Hospira Healthcare India Pvt. Ltd. SourceCGMP/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 9 May 2013Warning letter to Hospira Inc. SourceCGMP/QSR/Medical Devices/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 26 May 2010Warning letter to Pfizer, Inc. SourcePostmarketing Adverse Drug Experience Reporting Requirements · issued to the firm name; FDA does not tie it to this FEI
- 12 Apr 2010Warning letter to Hospira, Inc. SourceCGMP for Finished Pharmaceuticals/Deviations/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 9 Apr 2010Warning letter to Pfizer Inc. SourceSponsor · issued to the firm name; FDA does not tie it to this FEI
Import alerts in force
No listing in force under this firm's name.
Registration
- FEI
- 3008316085
- DUNS
- 860037912
- Registered as
- Pfizer Healthcare India Private Limited
- Registrant
- Hospira, Inc.
- Address
- Plot No. 116, 117, 118, 119, 111 (Part) and 123 (Part), Jawaharlal Nehru Pharma City (SEZ), Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK
- 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.