Aplicare, Inc.
Form 483 issued August 3, 2021 · Meriden, Connecticut
- Inspection
- Jul 12 – Aug 3, 2021
- Investigator
- Brandy N. Lepage
- Observations
- 4
- Pages
- 7
- FEI number
- 1220701
In short: On August 3, 2021, FDA issued a Form 483 with 4 observations to Aplicare, Inc. in Meriden, Connecticut (FEI 1220701) after an inspection that ran Jul 12 – Aug 3, 2021. The investigator was Brandy N. Lepage. Most observations concern facilities & equipment and production.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment for adequate control over micro-organisms is not provided when appropriate for the manufacture, processing, packing…
- 02
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAplicare, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.46(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aplicare, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Aplicare, Inc.?
Brandy N. Lepage is named on this Form 483, for the inspection of Jul 12 – Aug 3, 2021. Each investigator has a profile showing what they cite most.
When was Aplicare, Inc. inspected by FDA?
The inspection ran Jul 12 – Aug 3, 2021, and the Form 483 is dated August 3, 2021.
How do I get the full Form 483 for Aplicare, Inc.?
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.