Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2012-02-24.
At a glance
Inspections
5
Form 483s
4
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2012 | Not recorded | Clean | |
| 29 Oct 2010 | Not recorded | WL | View 483 → |
| 23 Aug 2010 | Not recorded | 483 | View 483 → |
| 23 Dec 2009 | Not recorded | 483 | On file |
| 23 Dec 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Oct 2010
21 CFR 111.70(b)(2)
Specifications-component purity, strength, composition
Cited by Raymond L Cheung, Dhaval H Patel
29 Oct 2010
21 CFR 111.70(c)(2)
Documentation specifications - contamination limits
Cited by Raymond L Cheung, Dhaval H Patel
29 Oct 2010
21 CFR 111.75(a)(2)(ii)(A)
Component - qualify supplier
Cited by Raymond L Cheung, Dhaval H Patel
29 Oct 2010
21 CFR 111.455(a)
Hold - temperature, humidity, light
Cited by Raymond L Cheung, Dhaval H Patel
Investigators
FDA investigators tied to this site in the record.
Dhaval H Patel2 insp.
Atul Agrawal1 insp.
Raymond L Cheung1 insp.
Doreen P Gubbay1 insp.
Edward Oshaughnessy1 insp.
Meredith L Sheridan1 insp.
Sean G Casey1 insp.
Eric Rothschild1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.455(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nutro Laboratories, a div of NBTY, Inc.'s 4 Form 483s
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