Alcon Singapore Manufacturing Pte. Ltd.
Form 483 issued September 8, 2023 · Singapore, Singapore
- Inspection
- Sep 4 – Sep 8, 2023
- Investigators
- Dogbeda F. Mackenzie· Jeffrey P. Raimondi
- Observations
- 5
- Pages
- 4
- FEI number
- 3010372291
In short: On September 8, 2023, FDA issued a Form 483 with 5 observations to Alcon Singapore Manufacturing Pte. Ltd. in Singapore, SG (FEI 3010372291) after an inspection that ran Sep 4 – Sep 8, 2023. The investigators were Dogbeda F. Mackenzie and Jeffrey P. Raimondi. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Dogbeda F. Mackenzie
14 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAlcon Singapore Manufacturing Pte. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcon Singapore Manufacturing Pte. Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Alcon Singapore Manufacturing Pte. Ltd.?
Dogbeda F. Mackenzie and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Sep 4 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Alcon Singapore Manufacturing Pte. Ltd. inspected by FDA?
The inspection ran Sep 4 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Alcon Singapore 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.