Pfizer Asia Manufacturing Pte Ltd.
Form 483 issued October 27, 2021 · Singapore, Singapore
- Inspection
- Oct 18 – Oct 27, 2021
- Investigator
- Arsen Karapetyan
- Observations
- 2
- Pages
- 2
- FEI number
- 3003901862
In short: On October 27, 2021, FDA issued a Form 483 with 2 observations to Pfizer Asia Manufacturing Pte Ltd. in Singapore, Singapore (FEI 3003901862) after an inspection that ran Oct 18 – Oct 27, 2021. The investigator was Arsen Karapetyan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42(c) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmPfizer Asia Manufacturing Pte Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pfizer Asia Manufacturing Pte Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Pfizer Asia Manufacturing Pte Ltd.?
Arsen Karapetyan is named on this Form 483, for the inspection of Oct 18 – Oct 27, 2021. Each investigator has a profile showing what they cite most.
When was Pfizer Asia Manufacturing Pte Ltd. inspected by FDA?
The inspection ran Oct 18 – Oct 27, 2021, and the Form 483 is dated October 27, 2021.
How do I get the full Form 483 for Pfizer Asia Manufacturing Pte Ltd.?
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.