Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-21.
At a glance
Inspections
8
Form 483s
5
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Feb 2024 – 21 Feb 2024 | Animal Drugs & Feeds | 483 | On file |
| 25 Jul 2022 – 29 Jul 2022 | Animal Drugs & Feeds | Clean | |
| 14 Jan 2019 – 18 Jan 2019 | Human Drugs | Clean | |
| 21 Jun 2018 – 28 Jun 2018 | Human Drugs | 483 | View 483 → |
| 9 Dec 2016 – 16 Dec 2016 | Human Drugs | 483 | On file |
| 27 Oct 2014 – 4 Nov 2014 | Human Drugs | 483 | View 483 → |
| 12 Dec 2012 | Not recorded | 483 | On file |
| 13 Oct 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Jun 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rachael A Moliver, Katie L Penno
28 Jun 2018
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Rachael A Moliver, Katie L Penno
28 Jun 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rachael A Moliver, Katie L Penno
28 Jun 2018
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Rachael A Moliver, Katie L Penno
28 Jun 2018
21 CFR 211.22(a)
Approve or reject components, products
Cited by Rachael A Moliver, Katie L Penno
Investigators
FDA investigators tied to this site in the record.
Cynthia Jim1 insp.
MRA M BarbosaR1 insp.
Niketa Patel1 insp.
Rachael A Moliver1 insp.
Katie L Penno1 insp.
Theresa Kirkham1 insp.
Constance Y Fears1 insp.
Lance M De Souza1 insp.
Regina T Brown1 insp.
Melanie M Walker1 insp.
Jawaid Hamid1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Haupt Pharma Latina Srl'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