Pfizer Healthcare India Private Limited
Form 483 issued September 6, 2019 · Visakhapatnam, India
- Investigator
- Jose E. Melendez
- Observations
- 3
- Pages
- 9
- FEI number
- 3008316085
In short: On September 6, 2019, FDA issued a Form 483 with 3 observations to Pfizer Healthcare India Private Limited in Visakhapatnam, Andhra Pradesh (FEI 3008316085). The investigator was Jose E. Melendez. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit are not fully followed. A. Your…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmPfizer Healthcare India Private Limited history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Healthcare India Private Limited?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Pfizer Healthcare India Private Limited?
Jose E. Melendez is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Pfizer Healthcare India Private Limited inspected by FDA?
This Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Pfizer Healthcare India Private Limited?
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.