Neolpharma, Inc.
FDA inspection history in Caguas, Puerto Rico, 2015 to 2026
- 5
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s, at Caguas, Puerto Rico.
- 2015The longest 483 on file: 7 observations over 10 pages at Caguas, Puerto Rico.
- 2022One Form 483, at Caguas, Puerto Rico.
- 2026One Form 483, at Caguas, Puerto Rico.
Cited most
Across all Neolpharma observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
The complete Neolpharma file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Caguas, Puerto Rico
Five Form 483s · 2015 to 2026 · 13 observations
Latest: Form 483, Mar 10, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-10 | 483 Form 483 | Caguas, Puerto Rico | 2 | $99 |
| 2022-04-01 | 483 Form 483 | Caguas, Puerto Rico | 1 | $99 |
| 2019-02-05 | 483 Form 483 | Caguas, Puerto Rico | 1 | $99 |
| 2017-06-07 | 483 Form 483 | Caguas, Puerto Rico | 2 | $99 |
| 2015-06-18 | 483 Form 483 | Caguas, Puerto Rico | 7 | $99 |
Investigators on these documents
Angelica M. Hernandez (2)Libia M. Lugo (2)Alan A. Rivera (1)Marian E. Ramirez (1)Rebeca Melendez (1)Brian J. Ryan (1)Ariel Cruz Figueroa (1)
FEI number 3009993897 · most recent document Mar 10, 2026
About Neolpharma, Inc.
How many FDA Form 483s has Neolpharma, Inc. received?
FDA Intel has 5 Form 483s on file for Neolpharma, Inc.; the most recent is dated Mar 10, 2026.
When was Neolpharma, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Neolpharma, Inc. is a Form 483 dated Mar 10, 2026, for the site in Caguas, Puerto Rico.
What did FDA cite at Neolpharma, Inc.?
The regulations cited most in the observations on file for Neolpharma, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times.