Pfizer Asia Manufacturing Pte Ltd.
Form 483 issued March 15, 2019 · Singapore, Singapore
- Inspection
- Mar 11 – Mar 15, 2019
- Investigator
- Justin A. Boyd
- Observations
- 6
- Pages
- 4
- FEI number
- 3003901862
In short: On March 15, 2019, FDA issued a Form 483 with 6 observations to Pfizer Asia Manufacturing Pte Ltd. in Singapore, Singapore (FEI 3003901862) after an inspection that ran Mar 11 – Mar 15, 2019. The investigator was Justin A. Boyd. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of unexpected occurrences…
- 02
Procedures for thoroughly reviewing data have not…
- 03
Quality reviews of the API do not verify the consistency of the process. 1. Trended data…
- 04
Cleaning procedures did not thoroughly evaluate the ability to prevent build-up…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) 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 211.192
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 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Pfizer Asia Manufacturing Pte Ltd.?
Justin A. Boyd is named on this Form 483, for the inspection of Mar 11 – Mar 15, 2019. Each investigator has a profile showing what they cite most.
When was Pfizer Asia Manufacturing Pte Ltd. inspected by FDA?
The inspection ran Mar 11 – Mar 15, 2019, and the Form 483 is dated March 15, 2019.
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.