Time Cap Labs, Inc.
Form 483 issued May 5, 1998 · Farmingdale, New York
- Inspection
- Mar 26 – May 5, 1998
- Investigators
- Lawrence Farina· Robert C. Horan
- Observations
- 25
- Pages
- 11
- FEI number
- 2431898
In short: On May 5, 1998, FDA issued a Form 483 with 25 observations to Time Cap Labs, Inc. in Farmingdale, New York (FEI 2431898) after an inspection that ran Mar 26 – May 5, 1998. The investigators were Lawrence Farina and Robert C. Horan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 17 of 20 observations.
Most cited: 21 CFR 211.192 (7×) · 211.100 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Capsules has included the…
- 02
The firm has not established an acceptance range for the amount of timing solution used in…
- 03
The master batch record$for manufacture of, Nitrog…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Lawrence Farina
2 documents · 1998
Cites 58.81 (standard operating procedures) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Time Cap Labs, Inc.?
FDA listed 25 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Time Cap Labs, Inc.?
Lawrence Farina and Robert C. Horan are named on this Form 483, for the inspection of Mar 26 – May 5, 1998. Each investigator has a profile showing what they cite most.
When was Time Cap Labs, Inc. inspected by FDA?
The inspection ran Mar 26 – May 5, 1998, and the Form 483 is dated May 5, 1998.
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.