McNeil Healthcare, LLC
FDA inspection history across 3 sites, 2001 to 2023
- 8
- Form 483s
- 2
- Responses
- 2
- EIRs
Every document, by year
- Form 483
- Response
- EIR
2001: one Form 483; 2002: one Form 483; 2006: one inspection report; 2008: one inspection report and one Form 483; 2010: three Form 483s and one 483 response; 2015: one warning letter response; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001–02Two Form 483s, at Las Piedras, Maryland.
- 2006–10Four Form 483s, two inspection reports and one 483 response, at Las Piedras, Puerto Rico and Las Piedras, Maryland.
- 2010The longest 483 on file: 7 observations over 8 pages at Las Piedras, Puerto Rico.
- 2015One warning letter response, at Maryland.
- 2021–23Two Form 483s, at Las Piedras, Puerto Rico.
Cited most
Across all McNeil Healthcare observations on file
- 21 CFR 211.192Production record review8
- 21 CFR 211.100Written procedures; deviations5
- 21 CFR 211.160General requirements4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.67Equipment cleaning and maintenance3
The complete McNeil Healthcare file.
All 12 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Las Piedras, Maryland
Five Form 483s and one inspection report · 2001 to 2010 · 18 observations
Latest: Form 483, Nov 2, 2010 →Las Piedras, Puerto Rico
Three Form 483s, one 483 response and one inspection report · 2006 to 2023 · 19 observations
Latest: Form 483, Sep 20, 2023 →Maryland
One warning letter response · 2015
Latest: Response, Jul 24, 2015 →
Documents
12 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-20 | 483 Form 483 | Las Piedras, Puerto Rico | 5 | $99 |
| 2021-03-31 | 483 Form 483 | Las Piedras, Puerto Rico | 7 | $99 |
| 2015-07-24 | Response Warning letter response | Maryland | — | $199 |
| 2010-11-02 | 483 Form 483 | Las Piedras, Maryland | 6 | $99 |
| 2010-02-05 | Response 483 response | Las Piedras, Puerto Rico | — | $199 |
| 2010-02-03 | 483 Form 483 | Las Piedras, Maryland | 1 | $99 |
| 2010-01-08 | 483 Form 483 | Las Piedras, Puerto Rico | 7 | $99 |
| 2008-08-06 | EIR EIR | Las Piedras, Maryland | — | $550 |
| 2008-08-06 | 483 Form 483 | Las Piedras, Maryland | 2 | $99 |
| 2006-04-07 | EIR EIR | Las Piedras, Puerto Rico | — | $550 |
| 2002-09-09 | 483 Form 483 | Las Piedras, Maryland | 5 | $99 |
| 2001-02-13 | 483 Form 483 | Las Piedras, Maryland | 4 | $99 |
Investigators on these documents
Jose E. Melendez (3)Jose R. Lopez (3)Jorge L. Lajara (2)Iraida Ortiz (2)Marian E. Ramirez (1)Marianela Aponte (1)Ramon A. Hernandez (1)Gonzalez Rivera (1)Raquel Gonzalez (1)Ileana Barreto-Pettit (1)Jorge L. Guadalupe (1)Jose M. Cayuela (1)
FEI number 2650141 · most recent document Sep 20, 2023
About McNeil Healthcare, LLC
How many FDA Form 483s has McNeil Healthcare, LLC received?
FDA Intel has 8 Form 483s on file for McNeil Healthcare, LLC; the most recent is dated Sep 20, 2023.
When was McNeil Healthcare, LLC last inspected by FDA?
The most recent FDA inspection document on file for McNeil Healthcare, LLC is a Form 483 dated Sep 20, 2023, for the site in Las Piedras, Puerto Rico.
What did FDA cite at McNeil Healthcare, LLC?
The regulations cited most in the observations on file for McNeil Healthcare, LLC are 21 CFR 211.192 (Production record review), 8 times; 21 CFR 211.100 (Written procedures; deviations), 5 times; 21 CFR 211.160 (General requirements), 4 times.