Time Cap Labs, Inc.
Form 483 issued December 18, 2019 · Farmingdale, New York
- Inspection
- Dec 5 – Dec 18, 2019
- Investigator
- Jay T. Wong
- Observations
- 3
- Pages
- 4
- FEI number
- 2431898
In short: On December 18, 2019, FDA issued a Form 483 with 3 observations to Time Cap Labs, Inc. in Farmingdale, New York (FEI 2431898) after an inspection that ran Dec 5 – Dec 18, 2019. The investigator was Jay T. Wong. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jay T. Wong
5 documents · 2019–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmTime Cap Labs, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Time Cap Labs, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Time Cap Labs, Inc.?
Jay T. Wong is named on this Form 483, for the inspection of Dec 5 – Dec 18, 2019. Each investigator has a profile showing what they cite most.
When was Time Cap Labs, Inc. inspected by FDA?
The inspection ran Dec 5 – Dec 18, 2019, and the Form 483 is dated December 18, 2019.
How do I get the full Form 483 for Time Cap Labs, 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.