Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-05-25.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 May 2021 – 25 May 2021 | Human Drugs | 483 | On file |
| 12 Jan 2015 – 23 Jan 2015 | Human Drugs | 483 | On file |
| 28 Feb 2013 – 8 Mar 2013 | Human Drugs | 483 | View 483 → |
| 22 Mar 2011 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Julianne C Mccullough, Barbara D Paul
8 Mar 2013
21 CFR 211.42(a)
Buildings of Suitable Size, Construction, Location
Cited by Julianne C Mccullough, Barbara D Paul
8 Mar 2013
21 CFR 211.56(b)
Written sanitation procedures lacking
Cited by Julianne C Mccullough, Barbara D Paul
8 Mar 2013
21 CFR 211.84(d)(3)
Testing Containers & Closures Conformity with Specs
Cited by Julianne C Mccullough, Barbara D Paul
Investigators
FDA investigators tied to this site in the record.
Jose M Cayuela1 insp.
Tracy A Denison1 insp.
Nicholas A Violand1 insp.
Anita Narula1 insp.
Julianne C Mccullough1 insp.
Barbara D Paul1 insp.
Bo Chi1 insp.
Mary E Farbman1 insp.
Anastasia G Lolas1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.94(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Public Health England'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