Twincraft Inc
Form 483 issued August 25, 2020 · Winooski, Vermont
- Inspection
- Aug 18 – Aug 25, 2020
- Investigator
- Edmund F. Mrak
- Observations
- 6
- Pages
- 7
- FEI number
- 1219963
In short: On August 25, 2020, FDA issued a Form 483 with 6 observations to Twincraft Inc in Winooski, Vermont (FEI 1219963) after an inspection that ran Aug 18 – Aug 25, 2020. The investigator was Edmund F. Mrak. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Laboratory controls and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written production and control procedures include batches fonnulated with the intent to provide less than 100…
- 02
The calibration of instruments is not…
- 03
Laboratory records are deficient in that they do not include the initials of the person perfonning…
- 04
Laboratory records do not include the initials or signature of a second person showing that the…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmTwincraft Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.101(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Twincraft Inc?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Twincraft Inc?
Edmund F. Mrak is named on this Form 483, for the inspection of Aug 18 – Aug 25, 2020. Each investigator has a profile showing what they cite most.
When was Twincraft Inc inspected by FDA?
The inspection ran Aug 18 – Aug 25, 2020, and the Form 483 is dated August 25, 2020.
How do I get the full Form 483 for Twincraft 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.