Overview
- 18 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-24.
At a glance
Inspections
18
Form 483s
12
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Apr 2025 – 24 Apr 2025 | Human Drugs | 483 | View 483 → |
| 4 Oct 2023 – 10 Oct 2023 | Foods & Cosmetics | Clean | |
| 5 Dec 2019 – 18 Dec 2019 | Human Drugs | 483 | View 483 → |
| 26 Feb 2018 – 12 Mar 2018 | Human Drugs | 483 | View 483 → |
| 1 Mar 2016 – 10 Mar 2016 | Human Drugs | 483 | View 483 → |
| 7 Jan 2015 – 16 Jan 2015 | Human Drugs | 483 | View 483 → |
| 23 Oct 2013 – 25 Oct 2013 | Human Drugs | Clean | |
| 13 Mar 2013 – 18 Mar 2013 | Human Drugs | 483 | View 483 → |
| 18 Nov 2011 | Not recorded | 483 | On file |
| 17 Feb 2011 | Not recorded | 483 | On file |
| 1 Apr 2010 | Not recorded | 483 | On file |
| 29 Jun 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2025
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Amatul H Marium, Emmanuel T Donyina
12 Mar 2018
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Robert C Horan
Investigators
FDA investigators tied to this site in the record.
James A Liubicich4 insp.
Robert C Horan2 insp.
Alice S Tsao2 insp.
Robert C Steyert2 insp.
Gary J Lehr2 insp.
Amatul H Marium1 insp.
Emmanuel T Donyina1 insp.
Tracy M Portelli1 insp.
Suwaskie S Smith1 insp.
Jay T Wong1 insp.
Edouard Viard1 insp.
Jaison J Eapen1 insp.
Charanjeet Jassal1 insp.
Charisse K Green1 insp.
Ann M Stewart1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Time-Cap Laboratories, Inc.'s 12 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat