Filltech USA, LLC
Form 483 issued April 14, 2022 · Rockwell, North Carolina
- Investigator
- Angelica M. Hernandez
- Observations
- 3
- Pages
- 3
- FEI number
- 1000512200
In short: On April 14, 2022, FDA issued a Form 483 with 3 observations to Filltech USA, LLC in Rockwell, North Carolina (FEI 1000512200). The investigator was Angelica M. Hernandez. Most observations concern facilities & equipment and materials.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Drug products are not stored under appropriate conditions of so that their identity, strength, quality, and…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmFilltech USA, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Filltech USA, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Filltech USA, LLC?
Angelica M. Hernandez is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Filltech USA, LLC inspected by FDA?
This Form 483 is dated April 14, 2022.
How do I get the full Form 483 for Filltech USA, LLC?
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.