Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-05-09.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2019 – 9 May 2019 | Human Drugs | 483 | View 483 → |
| 9 Apr 2018 – 7 May 2018 | Human Drugs | 483 | View 483 → |
| 19 Feb 2013 – 22 Feb 2013 | Human Drugs | 483 | On file |
| 23 Dec 2009 | Not recorded | 483 | On file |
| 21 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
9 May 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Jennifer L Huntington
9 May 2019
FDCA 501(a)(2)(A)
Actionable microbial contamination, adjacent area
Cited by Jennifer L Huntington
9 May 2019
FDCA 501(a)(2)(A)
Disinfecting and cleaning agents, ISO 5 area
Cited by Jennifer L Huntington
Investigators
FDA investigators tied to this site in the record.
Jennifer L Huntington2 insp.
Joanne E King1 insp.
Christie A Soto1 insp.
Ileana Barreto-Pettit1 insp.
Lesley K Satterwhite1 insp.
Robert C Steyert1 insp.
Mihaly S Ligmond1 insp.
Bill Tackett1 insp.
Leslie A Cartmill1 insp.
Daryl A Dewoskin1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| FDCA 501(a)(2)(A) | Cited across public-safe Form 483 observations | 9x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Coast Quality Pharmacy LLC's 5 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